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Trial record 46 of 142 for:    acne AND erythema

Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne

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ClinicalTrials.gov Identifier: NCT00706433
Recruitment Status : Completed
First Posted : June 27, 2008
Results First Posted : August 21, 2009
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):
DUSA Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: aminolevulinic acid HCL (ALA)
Other: Vehicle (VEH)
Enrollment 266
Recruitment Details Recruitment period: 3/7/07 - 3/31/08 Types of location: medical clinics
Pre-assignment Details no enrolled participants excluded from the trial before assignment to groups
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Period Title: Overall Study
Started 68 65 67 66
Completed 63 62 57 64
Not Completed 5 3 10 2
Reason Not Completed
Lost to Follow-up             3             1             6             0
Withdrawal by Subject             1             2             3             1
Adverse Event             0             0             1             0
Protocol Violation             1             0             0             0
new job             0             0             0             1
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds Total
Hide Arm/Group Description Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) Total of all reporting groups
Overall Number of Baseline Participants 68 65 67 66 266
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
<=18 years
41
  60.3%
44
  67.7%
33
  49.3%
37
  56.1%
155
  58.3%
Between 18 and 65 years
27
  39.7%
21
  32.3%
34
  50.7%
29
  43.9%
111
  41.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
20.0  (6.15) 19.4  (6.82) 21.3  (6.77) 19.8  (5.31) 20.1  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Female
30
  44.1%
35
  53.8%
38
  56.7%
35
  53.0%
138
  51.9%
Male
38
  55.9%
30
  46.2%
29
  43.3%
31
  47.0%
128
  48.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Hispanic or Latino
12
  17.6%
7
  10.8%
11
  16.4%
9
  13.6%
39
  14.7%
Not Hispanic or Latino
56
  82.4%
58
  89.2%
56
  83.6%
57
  86.4%
227
  85.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Edema  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Grade 0 (none) 65 64 65 65 259
Grade 1 (minimal) 3 1 2 1 7
Erythema  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Grade 0 (none) 37 34 41 36 148
Grade 1 (minimal) 24 20 16 21 81
Grade 2 (mild) 6 11 9 8 34
Grade 3 (moderate) 1 0 1 1 3
Fitzpatrick Skin Type  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Type I - never tans (sensitive) 0 3 2 3 8
Type II - tans minimally (sensitive) 16 13 14 19 62
Type III - tans gradually (light brown)(normal) 24 24 24 15 87
Type IV - always tans well (moderate brown) 17 15 15 16 63
Type V - tans profusely (dark brown) 7 4 6 10 27
Type VI - deeply pigmented (insensitive) 4 6 6 3 19
Hyperpigmentation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Grade 0 (none) 50 48 49 53 200
Grade 1 (light) 12 16 12 6 46
Grade 2 (moderate - small) 5 1 6 4 16
Grade 3 (moderate - moderate) 1 0 0 3 4
Hypopigmentation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Grade 0 (none) 65 65 67 64 261
Grade 1 (light) 3 0 0 2 5
Investigator Global Assessment of Acne Severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Grade 3 (moderate severity) 28 37 31 31 127
Grade 4 (severe) 40 28 36 35 139
[1]
Measure Description: Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions)
Oozing/vesiculation.crusting  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Grade 0 (none) 62 62 63 64 251
Grade 1 (minimal) 3 3 1 2 9
Grade 2 (mild) 3 0 3 0 6
Scaling and Dryness  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Grade 0 (none) 53 47 44 46 190
Grade 1 (minimal) 13 14 20 17 64
Grade 2 (mild) 2 3 2 2 9
Grade 3 (moderate) 0 1 0 1 2
Grade 4 (severe) 0 0 1 0 1
Stinging/Burning  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
Grade 0 (none) 64 63 66 63 256
Grade 1 (minimal) 4 2 1 3 10
Number of Inflammatory Lesions  
Median (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 68 participants 65 participants 67 participants 66 participants 266 participants
50.0  (35.8) 44.0  (27.0) 49.0  (34.8) 41.5  (26.6) 44.5  (31.4)
1.Primary Outcome
Title Change in Inflammatory Lesion Counts Relative to Baseline
Hide Description [Not Specified]
Time Frame Baseline and 3 weeks after final treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis, LOCF
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Median (Standard Deviation)
Unit of Measure: change in lesion count
-18.0  (26.3) -14.0  (26.8) -19.0  (22.8) -14.5  (24.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7680
Comments [Not Specified]
Method ANCOVA
Comments Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.
2.Primary Outcome
Title Investigator Global Assessment of Acne Severity Successes
Hide Description Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.
Time Frame Baseline and 3 weeks after final treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT LOCF
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Measure Type: Number
Unit of Measure: participants
Success 13 11 15 11
Failure 55 54 52 55
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Null hypothesis: equal success rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7975
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
3.Secondary Outcome
Title Percent Change in Inflammatory Lesion Counts Relative to Baseline
Hide Description [Not Specified]
Time Frame Baseline and 3 weeks after final treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT LOCF
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Median (Standard Deviation)
Unit of Measure: percent change in lesion count
-37.5  (38.79) -29.2  (46.68) -41.7  (38.82) -37.0  (40.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.10
Comments [Not Specified]
Method ANOVA
Comments Rank transformed data.
4.Secondary Outcome
Title Percent Change in Inflammatory Lesion Counts Relative to Baseline
Hide Description [Not Specified]
Time Frame Baseline and 6 weeks after final treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT LOCF
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Median (Standard Deviation)
Unit of Measure: percent change in lesion count
-34.4  (37.8) -29.0  (42.57) -48.4  (32.81) -45.2  (50.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.10
Comments [Not Specified]
Method ANOVA
Comments Rank transformed data.
5.Secondary Outcome
Title Subject Satisfaction Score
Hide Description

Subject satisfaction score

  1. = Excellent (very satisfied)
  2. = Good (moderately satisfied)
  3. = Fair (slightly satisfied)
  4. = Poor (not satisfied at all)
Time Frame 6 weeks after final treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 64 61 58 66
Measure Type: Number
Unit of Measure: participants
Excellent 23 11 23 26
Good 18 28 20 23
Fair 17 17 11 12
Poor 6 5 4 5
6.Secondary Outcome
Title Change in Inflammatory Lesion Counts Relative to Baseline
Hide Description change in lesion counts compared to baseline
Time Frame Baseline and 6 weeks after final treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT LOCF
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Median (Standard Deviation)
Unit of Measure: change in lesion count
-18.5  (30.15) -13.0  (28.74) -21.0  (23.63) -17.0  (26.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1103
Comments [Not Specified]
Method ANCOVA
Comments Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.
7.Secondary Outcome
Title Investigator Global Assessment of Acne Severity Successes
Hide Description

Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline.

0 Clear skin with no inflam or non-inflam lesions

  1. Almost clear; rare non-inflam lesions with no more than a few small inflam lesions
  2. Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)
  3. Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule
  4. Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules
Time Frame Baesline and 6 weeks after final treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT LOCF
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Measure Type: Number
Unit of Measure: participants
Success 15 11 16 16
Failure 53 54 51 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Null hypothesis: equal success rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7228
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
8.Secondary Outcome
Title Hyperpigmentation 48 Hours After PDT #1
Hide Description  HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time Frame 48 hours after PDT #1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 66 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 49 49 49 53
Grade 1 (light) 14 14 10 7
Grade 2 (moderate - small) 4 1 7 3
Grade 3 (moderate - mod) 1 0 0 3
Grade 4 (marked) 0 1 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3416
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
9.Secondary Outcome
Title Hyperpigmentation at Visit 3 (Week 3)
Hide Description  HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time Frame Visit 3 (Week 3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 64 62 62 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 49 50 48 52
Grade 1 (light) 10 10 10 8
Grade 2 (moderate - small) 4 2 4 4
Grade 3 (moderate - mod) 1 0 0 2
Grade 4 (marked) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5759
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
10.Secondary Outcome
Title Hyperpigmentation at Visit 5 (Week 6)
Hide Description  HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time Frame Visit 5 (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 63 60 63
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 44 51 46 49
Grade 1 (light) 13 9 12 8
Grade 2 (moderate - small) 3 3 2 4
Grade 3 (moderate - mod) 2 0 0 2
Grade 4 (marked) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4754
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
11.Secondary Outcome
Title Hyperpigmentation at Visit 7 (Week 9)
Hide Description  HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time Frame Visit 7 (Week 9)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 63 62 57 65
Measure Type: Number
Unit of Measure: participant
Grade 0 (none) 49 49 45 52
Grade 1 (light) 9 11 11 10
Grade 2 (moderate - small) 4 2 1 3
Grade 3 (moderate - mod) 1 0 0 0
Grade 4 (marked) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4096
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
12.Secondary Outcome
Title Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)
Hide Description  HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time Frame Visit 9 (3 weeks after final PDT)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 61 57 63
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 45 49 43 51
Grade 1 (light) 12 10 11 7
Grade 2 (moderate - small) 5 2 3 5
Grade 3 (moderate - mod) 0 0 0 0
Grade 4 (marked) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5812
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
13.Secondary Outcome
Title Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)
Hide Description  HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time Frame Visit 10 (6 weeks after final PDT)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 63 62 57 64
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 48 50 46 50
Grade 1 (light) 12 9 7 10
Grade 2 (moderate - small) 1 2 4 3
Grade 3 (moderate - mod) 2 1 0 1
Grade 4 (marked) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8679
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
14.Secondary Outcome
Title Hypopigmentation 48 Hours Post PDT #1
Hide Description  HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time Frame 48 hours post PDT #1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 66 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 67 64 65 64
Grade 1 (light) 1 1 0 2
Grade 2 (moderate - small) 0 0 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3666
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
15.Secondary Outcome
Title Hypopigmentation at Visit 3 (Week 3)
Hide Description  HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time Frame Visit 3 (Week 3)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 64 62 62 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 61 62 61 65
Grade 1 (light) 2 0 1 1
Grade 2 (moderate - small) 1 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3080
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
16.Secondary Outcome
Title Hypopigmentation at Visit 5 (Week 6)
Hide Description  HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time Frame Visit 5 (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 63 60 63
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 59 63 60 63
Grade 1 (light) 3 0 0 0
Grade 2 (moderate - small) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
17.Secondary Outcome
Title Hypopigmentation at Visit 7 (Week 9)
Hide Description  HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time Frame Visit 7 (Week 9)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 63 62 57 65
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 61 62 57 65
Grade 1 (light) 2 0 0 0
Grade 2 (moderate - small) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
18.Secondary Outcome
Title Hypopigmentation at Visit 9 (3 Weeks After Final PDT)
Hide Description  HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time Frame Visit 9 (3 weeks after final PDT)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 61 57 63
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 58 61 57 63
Grade 1 (light) 4 0 0 0
Grade 2 (moderate - small) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
19.Secondary Outcome
Title Hypopigmentation at Visit 10 (6 Weeks After Final PDT)
Hide Description  HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time Frame Visit 10 (6 weeks after final PDT)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 63 62 57 64
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 60 62 57 64
Grade 1 (light) 2 0 0 0
Grade 2 (moderate - small) 1 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3916
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
20.Secondary Outcome
Title Erythema at Baseline (Pre-light)
Hide Description

After solution application, prior to light treatment

 Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time Frame Baseline (pre-light)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 29 31 35 29
Grade 1 (minimal) 24 20 19 25
Grade 2 (mild) 13 13 12 12
Grade 3 (moderate) 2 1 1 0
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8387
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
21.Secondary Outcome
Title Erythema at Baseline - Post Light Treatment
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Baseline - post light treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 16 18 22 21
Grade 1 (minimal) 23 24 19 27
Grade 2 (mild) 26 16 22 15
Grade 3 (moderate) 3 7 4 3
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1489
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
22.Secondary Outcome
Title Erythema 48 Hours After PDT #1
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame 48 hours after PDT #1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 66 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 19 16 34 29
Grade 1 (minimal) 24 21 25 30
Grade 2 (mild) 14 23 6 7
Grade 3 (moderate) 10 3 1 0
Grade 4 (severe) 1 2 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4143
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, Vehicle 1000 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALA 500 Seconds, Vehicle 1000 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ALA 500 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9700
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
23.Secondary Outcome
Title Erythema at Visit 3 (Week 3 - Pre Study Drug Application)
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Visit 3 (Week 3 - pre study drug application)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 64 62 62 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 36 35 34 34
Grade 1 (minimal) 20 16 23 23
Grade 2 (mild) 8 11 5 9
Grade 3 (moderate) 0 0 0 0
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2544
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
24.Secondary Outcome
Title Erythema at Visit 3 (Week 3 - Pre-light)
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Visit 3 (Week 3 - pre-light)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 61 62 65
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 27 30 27 32
Grade 1 (minimal) 24 18 27 20
Grade 2 (mild) 11 12 7 12
Grade 3 (moderate) 0 1 1 1
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4321
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
25.Secondary Outcome
Title Erythema at Visit 3 (Week 3 - Post Light Treatment)
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Visit 3 (Week 3 - post light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 61 62 65
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 13 16 18 21
Grade 1 (minimal) 28 20 30 23
Grade 2 (mild) 17 18 13 19
Grade 3 (moderate) 4 6 1 2
Grade 4 (severe) 0 1 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0317
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5818
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, Vehicle 1000 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0395
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7426
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALA 500 Seconds, Vehicle 1000 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ALA 500 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2142
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0781
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
26.Secondary Outcome
Title Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Visit 5 (Week 6 - prior to study drug application)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 63 60 63
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 36 35 31 34
Grade 1 (minimal) 20 21 22 23
Grade 2 (mild) 6 7 7 6
Grade 3 (moderate) 0 0 0 0
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9886
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
27.Secondary Outcome
Title Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Visit 5 (Weeks 6 - pre-light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 58 61 60 62
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 27 20 22 29
Grade 1 (minimal) 22 28 29 21
Grade 2 (mild) 9 12 9 11
Grade 3 (moderate) 0 1 0 1
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6907
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
28.Secondary Outcome
Title Erythema at Visit 5 (Week 6 - Post Light Treatment)
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Visit 5 (Week 6 - post light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 58 61 60 62
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 18 13 15 19
Grade 1 (minimal) 16 18 28 24
Grade 2 (mild) 19 24 15 17
Grade 3 (moderate) 4 6 2 2
Grade 4 (severe) 1 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6116
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, Vehicle 1000 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0209
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0513
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALA 500 Seconds, Vehicle 1000 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ALA 500 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0089
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5260
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
29.Secondary Outcome
Title Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Visit 7 (Week 9 - prior to study drug application)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 63 62 57 65
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 37 34 31 36
Grade 1 (minimal) 23 22 22 25
Grade 2 (mild) 3 6 4 4
Grade 3 (moderate) 0 0 0 0
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7820
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
30.Secondary Outcome
Title Erythema at Visit 7 (Week 9 - Pre Light Treatment)
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Visit 7 (Week 9 - pre light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 56 60 56 62
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 28 26 28 33
Grade 1 (minimal) 16 24 16 21
Grade 2 (mild) 11 8 11 7
Grade 3 (moderate) 1 2 1 1
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4965
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
31.Secondary Outcome
Title Erythema at Visit 7 (Week 9 - Post Light Treatment)
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame Visit 7 (Week 9 - post light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 56 60 56 62
Measure Type: Number
Unit of Measure: participant
Grade 0 (none) 20 14 20 18
Grade 1 (minimal) 13 18 19 23
Grade 2 (mild) 22 21 15 19
Grade 3 (moderate) 1 7 2 2
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0728
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
32.Secondary Outcome
Title Erythema 3 Weeks After Final PDT
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame 3 Weeks after Final PDT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 61 57 63
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 36 35 32 42
Grade 1 (minimal) 21 18 21 16
Grade 2 (mild) 5 8 4 5
Grade 3 (moderate) 0 0 0 0
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5480
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
33.Secondary Outcome
Title Erythema 6 Weeks After Final PDT
Hide Description Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time Frame 6 Weeks after Final PDT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 63 62 57 64
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 39 33 30 43
Grade 1 (minimal) 21 20 22 20
Grade 2 (mild) 3 9 5 1
Grade 3 (moderate) 0 0 0 0
Grade 4 (severe) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0301
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0564
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, Vehicle 1000 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4470
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2804
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALA 500 Seconds, Vehicle 1000 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1835
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ALA 500 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0103
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1319
Comments Not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
34.Secondary Outcome
Title Edema at Baseline - Pre Light Treatment
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Baseline - pre light treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 65 63 64 65
Grade 1 (minimal) 3 2 3 1
Grade 2 (mild) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
35.Secondary Outcome
Title Edema at Baseline - Post Light Treatment
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Baseline - Post Light Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 67 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 62 63 64 65
Grade 1 (minimal) 5 2 3 1
Grade 2 (mild) 1 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4378
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
36.Secondary Outcome
Title Edema 48 Hours After PDT #1
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame 48 hours after PDT #1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 68 65 66 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 64 57 61 64
Grade 1 (minimal) 4 7 5 2
Grade 2 (mild) 0 1 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3430
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
37.Secondary Outcome
Title Edema at Visit 3 (Week 3 - Before Study Drug Application)
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Visit 3 (Week 3 - before study drug application)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 64 62 62 66
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 62 61 61 66
Grade 1 (minimal) 2 1 1 0
Grade 2 (mild) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
38.Secondary Outcome
Title Edema at Visit 3 (Week 3 - Before Light Treatment)
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Visit 3 (Week 3 - before light treatment)
Hide Outcome Measure Data
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ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 61 62 65
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 60 60 61 65
Grade 1 (minimal) 2 1 1 0
Grade 2 (mild) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
39.Secondary Outcome
Title Edema at Visit 3 (Week 3 - Post Light Treatment)
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Visit 3 (Week 3 - post light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 61 62 65
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 60 59 61 64
Grade 1 (minimal) 2 2 1 1
Grade 2 (mild) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
40.Secondary Outcome
Title Edema at Visit 5 (Week 6 - Before Study Drug Application)
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Visit 5 (Week 6 - before study drug application)
Hide Outcome Measure Data
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ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 62 63 60 63
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 60 63 59 62
Grade 1 (minimal) 2 0 1 1
Grade 2 (mild) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
41.Secondary Outcome
Title Edema at Visit 5 (Week 6 - Pre Light Treatment)
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Visit 5 (Week 6 - pre light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 58 61 60 62
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 56 61 59 61
Grade 1 (minimal) 2 0 1 1
Grade 2 (mild) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
42.Secondary Outcome
Title Edema at Visit 5 (Week 6 - Post Light Treatment)
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Visit 5 (Week 6 - post light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 58 61 60 62
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 55 61 57 62
Grade 1 (minimal) 3 0 3 0
Grade 2 (moderate) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
43.Secondary Outcome
Title Edema at Visit 7 (Week 9 - Before Study Drug Application)
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Visit 7 (Week 9 - before study drug application)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 63 62 57 65
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 60 62 56 65
Grade 1 (minimal) 3 0 1 0
Grade 2 (mild) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
44.Secondary Outcome
Title Edema at Visit 7 (Week 9 - Prior to Light Treatment)
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Visit 7 (Week 9 - prior to light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds
Hide Arm/Group Description:
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Number of Participants Analyzed 56 60 56 62
Measure Type: Number
Unit of Measure: participants
Grade 0 (none) 53 59 56 62
Grade 1 (minimal) 3 1 0 0
Grade 2 (mild) 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALA 1000 Seconds, ALA 500 Seconds, Vehicle 1000 Seconds, Vehicle 500 Seconds
Comments Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by study center.
45.Secondary Outcome
Title Edema at Visit 7 (Week 9 - Post Light Treatment)
Hide Description EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time Frame Visit 7 (Week 9 - post light treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT observed
Arm/Group Title ALA 1000 Seconds ALA 500 Seconds Vehicle 1000 Seconds Vehicle 500 Seconds