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Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00594425
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : August 8, 2013
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):
Photocure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Intervention Drug: Methyl aminolevulinate (MAL) PDT
Enrollment 150
Recruitment Details First patient entered: February 07, 2007 Last patient last visit (12 week follow-up: July 07, 2008 Last patient last visit (24 week follow-up: September 22, 2008 15 medical derm clinics
Pre-assignment Details Washout periods for prior acne treatment: 14 days for any topical treatment (except medicated cleansers), 1 month for oral antibiotics; 6 months for oral isotretinoin. Patients using birth control pills must have used the same product and dose for at least 6 months and had to agree to stay with the same product and dose for an additional 6 months.
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 50 48 52
Completed 43 34 42
Not Completed 7 14 10
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 50 48 52 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 52 participants 150 participants
<=18 years
11
  22.0%
17
  35.4%
11
  21.2%
39
  26.0%
Between 18 and 65 years
39
  78.0%
31
  64.6%
41
  78.8%
111
  74.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 48 participants 52 participants 150 participants
21.6  (5.24) 20.2  (4.81) 22.0  (5.00) 21.3  (5.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 52 participants 150 participants
Female
28
  56.0%
27
  56.3%
36
  69.2%
91
  60.7%
Male
22
  44.0%
21
  43.8%
16
  30.8%
59
  39.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 48 participants 52 participants 150 participants
50 48 52 150
Inflammatory lesion count  
Mean (Full Range)
Unit of measure:  Lesions
Number Analyzed 50 participants 48 participants 52 participants 150 participants
34.2
(20 to 81)
32.1
(19 to 60)
31.2
(20 to 74)
32.5
(19 to 81)
Non inflammatory lesion count  
Mean (Full Range)
Unit of measure:  Lesions
Number Analyzed 50 participants 48 participants 52 participants 150 participants
39.1
(4 to 99)
35.9
(5 to 111)
35.2
(7 to 94)
36.7
(4 to 111)
Investigator's Global Assessment (IGA) Score  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 52 participants 150 participants
IGA SCORE 3 (MODERATE ACNE) 35 41 44 120
IGA SCORE 4 (SEVERE ACNE) 15 7 8 30
Fitzpatrick Skin type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 52 participants 150 participants
Fitzpatrick skin type score I 4 4 1 9
Fitzpatrick skin type score II 11 11 15 37
Fitzpatrick skin type score III 21 24 23 68
Fitzpatrick skin type score IV 14 9 13 36
[1]
Measure Description:

The patients is scored according to a predefined description of 4 different skin types.

I White; very fair; red or blond hair; blue eyes; freckles Always burns, never tans

II White; fair; red or blond hair; blue, hazel or green eyes Usually burns, tans with difficulty

III Cream white; fair with any eye or hair color; very common Sometimes mild burn, gradually tans

IV Brown; typical Mediterranean Caucasian skin Rarely burns, tans with ease

1.Primary Outcome
Title Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
Hide Description [Not Specified]
Time Frame 12 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 48 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
16
(8.34 to 28.51)
14.58
(7.25 to 27.17)
11.54
(5.40 to 22.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40 mg/g MAL PDT, Vehicle PDT
Comments H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5288
Comments Priori threshold for statistical significance was 5%
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done
Method of Estimation Estimation Parameter % success rate
Estimated Value 5.53
Confidence Interval (2-Sided) 95%
-7.97 to 19.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 80 mg/g MAL PDT, Vehicle PDT
Comments H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7539
Comments Priori threshold for statistical significance was 5%
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done
Method of Estimation Estimation Parameter % success rate
Estimated Value 3.95
Confidence Interval (2-Sided) 95%
-8.79 to 16.69
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
Hide Description [Not Specified]
Time Frame 12 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 48 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: lesions
-10.72
(-14.45 to -6.99)
-9.27
(-13.25 to -5.3)
-8.08
(-11.8 to -4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40 mg/g MAL PDT, Vehicle PDT
Comments H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3236
Comments Priori threshold for statistical significance was 5%
Method ANCOVA
Comments ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -2.64
Confidence Interval (2-Sided) 95%
-7.91 to 2.63
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 80 mg/g MAL PDT, Vehicle PDT
Comments H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6657
Comments Priori threshold for statistical significance was 5%
Method ANCOVA
Comments ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -1.19
Confidence Interval (2-Sided) 95%
-6.64 to 4.26
Estimation Comments [Not Specified]
3.Primary Outcome
Title Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
Hide Description [Not Specified]
Time Frame 12 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 42 40 33
Measure Type: Number
Unit of Measure: percentage of participants
17.5 21.2 16.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40 mg/g MAL PDT, Vehicle PDT
Comments H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7889
Comments Priori threshold for statistical significance was 5%
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel stratified by center. No adjustment for multiple comparisons was done
Method of Estimation Estimation Parameter %success rate
Estimated Value 3.09
Confidence Interval (2-Sided) 95%
-11.16 to 17.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 80 mg/g MAL PDT, Vehicle PDT
Comments H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8880
Comments Priori threshold for statistical significance was 5%
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done
Method of Estimation Estimation Parameter Percent success
Estimated Value 5.48
Confidence Interval (2-Sided) 95%
-10.15 to 21.11
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 42 40 33
Least Squares Mean (95% Confidence Interval)
Unit of Measure: lesions
-10.95
(-15.18 to -6.72)
-11.8
(-16.65 to -6.95)
-10.62
(-15.12 to -6.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40 mg/g MAL PDT, Vehicle PDT
Comments H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9151
Comments Priori threshold for statistical significance was 5%
Method ANCOVA
Comments ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-6.53 to 5.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 80 mg/g MAL PDT, Vehicle PDT
Comments H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7233
Comments Priori threshold for statistical significance was 5%
Method ANCOVA
Comments ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -1.18
Confidence Interval (2-Sided) 95%
-7.81 to 5.45
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Hide Description [Not Specified]
Time Frame 3 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 40 33 42
Median (Full Range)
Unit of Measure: Percentage change
-44.5
(-89 to 42)
-56.0
(-95 to 44)
-40.5
(-100 to 71)
6.Secondary Outcome
Title Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Hide Description [Not Specified]
Time Frame 6 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 40 33 42
Median (Full Range)
Unit of Measure: Percentage change
-52.0
(-92 to 88)
-69.5
(-95 to 45)
-52.0
(-96 to 71)
7.Secondary Outcome
Title Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
Hide Description [Not Specified]
Time Frame 6 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 40 33 42
Median (Full Range)
Unit of Measure: Percentage change
-38.5
(-89 to 160)
-48.0
(-95 to 104)
-38.0
(-100 to 225)
8.Secondary Outcome
Title Percent Reduction in Total Lesion Counts From Baseline
Hide Description [Not Specified]
Time Frame 6 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 38 32 41
Median (Full Range)
Unit of Measure: Percentage change
-40
(-88 to 66)
-54
(-87 to 68)
-37
(-94 to 100)
9.Secondary Outcome
Title Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
Hide Description [Not Specified]
Time Frame 6 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 42 40 33
Measure Type: Number
Unit of Measure: Precentage of participants
10.5 18.8 12.2
10.Secondary Outcome
Title The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment
Hide Description [Not Specified]
Time Frame 12 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 40 33 42
Measure Type: Number
Unit of Measure: percentage of participants
10.0 18.2 11.9
11.Secondary Outcome
Title Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Hide Description Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time Frame immediately after illumination-first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 48 52
Median (Full Range)
Unit of Measure: cm
2.05
(0.0 to 10.0)
2.25
(0.0 to 9.0)
0.00
(0.0 to 3.5)
12.Secondary Outcome
Title Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain
Hide Description Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time Frame immediately after second treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 46 41 50
Mean (Full Range)
Unit of Measure: cm
2.0
(0.0 to 7.5)
3.0
(0.0 to 8.0)
0.0
(0.0 to 2.0)
13.Secondary Outcome
Title Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Hide Description Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time Frame immediately after third treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 46 38 48
Median (Full Range)
Unit of Measure: cm
1.5
(0.0 to 8.0)
2.0
(0.0 to 6.0)
0.0
(0.0 to 1.0)
14.Secondary Outcome
Title Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Hide Description Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time Frame immediately after illumination-fourth treatment treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 45 37 46
Median (Full Range)
Unit of Measure: cm
1.10
(0.0 to 6.4)
2.50
(0.0 to 7.0)
0.0
(0.0 to 2.4)
15.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Erythema After First Treatment
Hide Description [Not Specified]
Time Frame immediately after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 48 52
Measure Type: Number
Unit of Measure: percentage of participants
75.1 61.7 17.6
16.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Erythema After First Treatment
Hide Description [Not Specified]
Time Frame 2 days after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 48 52
Measure Type: Number
Unit of Measure: percentage of participants
44.9 44.7 17.6
17.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Erythema After Second Treatment
Hide Description [Not Specified]
Time Frame immediately after second treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 48 52
Measure Type: Number
Unit of Measure: percentage of participants
67.4 65.8 18.0
18.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Erythema After Third Treatment
Hide Description [Not Specified]
Time Frame immediately after third treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 48 52
Measure Type: Number
Unit of Measure: percentage of participants
67.4 71.1 16.7
19.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
Hide Description [Not Specified]
Time Frame immediately after fourth treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 48 54
Measure Type: Number
Unit of Measure: percentage of participants
45.9 63.1 15.2
20.Secondary Outcome
Title Proportion of Patients With Severe Erythema After First Treatment
Hide Description [Not Specified]
Time Frame immediately after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 48 52
Measure Type: Number
Unit of Measure: percentage of participants
0.0 2.1 0.0
21.Secondary Outcome
Title Proportion of Patients With Severe Erythema 2 Days After First Treatment
Hide Description [Not Specified]
Time Frame 2 days after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 47 51
Measure Type: Number
Unit of Measure: percentage of participants
2.0 0.0 0.0
22.Secondary Outcome
Title Proportion of Patients With Severe Erythema 7 Days After First Treatment
Hide Description [Not Specified]
Time Frame 7 days after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 46 51
Measure Type: Number
Unit of Measure: percentage of participants
2.0 0.0 0.0
23.Secondary Outcome
Title Proportion of Patients With Severe Erythema After Second Treatment
Hide Description [Not Specified]
Time Frame immediately after second treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 46 41 50
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
24.Secondary Outcome
Title Proportion of Patients With Severe Erythema After Third Treatment
Hide Description [Not Specified]
Time Frame immediately after third treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 46 38 48
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
25.Secondary Outcome
Title Proportion of Patients With Severe Erythema After Fourth Treatment
Hide Description [Not Specified]
Time Frame immediately after fourth treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 45 38 46
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
26.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Hide Description [Not Specified]
Time Frame 2 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 48 47 51
Measure Type: Number
Unit of Measure: percentage of participants
6.3 4.3 5.9
27.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Hide Description [Not Specified]
Time Frame 2 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 46 51
Measure Type: Number
Unit of Measure: percentage of participants
2.0 10.8 5.9
28.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Hide Description [Not Specified]
Time Frame 2 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 46 38 45
Measure Type: Number
Unit of Measure: percentage of participants
8.6 21.1 4.4
29.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Hide Description [Not Specified]
Time Frame 6 weeks after last treatment
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Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 44 37 43
Measure Type: Number
Unit of Measure: percentage of participants
6.8 8.1 9.3
30.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Hide Description [Not Specified]
Time Frame 12 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 45 38 45
Measure Type: Number
Unit of Measure: percentage of participants
4.4 5.3 6.7
31.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Hide Description [Not Specified]
Time Frame 2 days after first treatment
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Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 48 47 51
Measure Type: Number
Unit of Measure: percentage of participants
2.1 0.0 0.0
32.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Hide Description [Not Specified]
Time Frame 2 weeks after last treatment
Hide Outcome Measure Data
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Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 46 38 45
Measure Type: Number
Unit of Measure: percentage of participants
4.4 0.0 2.2
33.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Hide Description [Not Specified]
Time Frame 2 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 46 51
Measure Type: Number
Unit of Measure: percentage of participants
2.0 0.0 0.0
34.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Hide Description [Not Specified]
Time Frame 6 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 44 37 43
Measure Type: Number
Unit of Measure: percentage of participants
2.3 2.7 0.0
35.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Hide Description [Not Specified]
Time Frame 12 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 45 38 45
Measure Type: Number
Unit of Measure: percentage of participants
2.2 0.0 0.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/50 (4.00%)   0/48 (0.00%)   0/52 (0.00%) 
Infections and infestations       
CELLULITIS STAPHYLOCOCCAL  1/50 (2.00%)  0/48 (0.00%)  0/52 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
PREGNANCY  1/50 (2.00%)  0/48 (0.00%)  0/52 (0.00%) 
ABORTION SPONTANEOUS  1/50 (2.00%)  0/48 (0.00%)  0/52 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
40 mg/g MAL PDT 80 mg/g MAL PDT Vehicle PDT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/50 (100.00%)   46/48 (95.83%)   38/52 (73.08%) 
Immune system disorders       
SEASONAL ALLERGY  0/50 (0.00%)  3/48 (6.25%)  1/52 (1.92%) 
Infections and infestations       
INFLUENZA  0/50 (0.00%)  1/48 (2.08%)  4/52 (7.69%) 
NASOPHARYNGITIS  3/50 (6.00%)  1/48 (2.08%)  1/52 (1.92%) 
SINUSITIS  0/50 (0.00%)  4/48 (8.33%)  4/52 (7.69%) 
UPPER RESPIRATORY TRACT INFECTION  9/50 (18.00%)  3/48 (6.25%)  9/52 (17.31%) 
Nervous system disorders       
Headache  2/50 (4.00%)  2/48 (4.17%)  0/52 (0.00%) 
Skin and subcutaneous tissue disorders       
APPLICATION SITE DISCOLOURATION  3/50 (6.00%)  7/48 (14.58%)  3/52 (5.77%) 
APPLICATION SITE DRYNESS  1/50 (2.00%)  3/48 (6.25%)  0/52 (0.00%) 
APPLICATION SITE ERYTHEMA  40/50 (80.00%)  35/48 (72.92%)  17/52 (32.69%) 
APPLICATION SITE EXFOLIATION  3/50 (6.00%)  3/48 (6.25%)  0/52 (0.00%) 
APPLICATION SITE IRRITATION  31/50 (62.00%)  26/48 (54.17%)  4/52 (7.69%) 
APPLICATION SITE PAIN  32/50 (64.00%)  31/48 (64.58%)  5/52 (9.62%) 
APPLICATION SITE PARAESTHESIA  3/50 (6.00%)  9/48 (18.75%)  4/52 (7.69%) 
APPLICATION SITE PRURITUS  13/50 (26.00%)  10/48 (20.83%)  5/52 (9.62%) 
APPLICATION SITE SCAB  3/50 (6.00%)  3/48 (6.25%)  0/52 (0.00%) 
APPLICATION SITE WARMTH  2/50 (4.00%)  0/48 (0.00%)  4/52 (7.69%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All data from the study are free for publication. However if publication of the results may endanger adequate patent protection for new principles,compounds,or formulations,Photocure has the right to decide when the results are free to be published. Before this agreed time, no data from the trial will be published, presented, or communicated, except to regulatory authorities and ethics committees. Both the investigators and Photocure will be given 30 days to review and comment.
Results Point of Contact
Name/Title: David Pariser MD
Organization: Virginia Clinical Research, Inc
Phone: 757-625-0151
Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT00594425     History of Changes
Other Study ID Numbers: PC TA202B/06
First Submitted: January 3, 2008
First Posted: January 15, 2008
Results First Submitted: March 14, 2013
Results First Posted: August 8, 2013
Last Update Posted: August 8, 2013