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Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

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: NCT00933543
Recruitment Status : Completed
First Posted : July 7, 2009
Results First Posted : November 15, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Photocure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Visonac PDT (MAL PDT)
Drug: Vehicle cream (placebo)
Procedure: PDT
Enrollment 107
Recruitment Details Recruitment from September-December 2009. Dermatology clinics, with pediatric patients
Pre-assignment Details  
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description Active treatment, Light dose 37 J/cm2. Placebo treatment, Light dose 37 J/cm2.
Period Title: Overall Study
Started 54 53
Completed 51 46
Not Completed 3 7
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
Lack of Efficacy             0             3
Other             1             1
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT Total
Hide Arm/Group Description Active treatment, Light dose 37 J/cm2. Placebo treatment, Light dose 37 J/cm2. Total of all reporting groups
Overall Number of Baseline Participants 54 53 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
<=18 years
35
  64.8%
34
  64.2%
69
  64.5%
Between 18 and 65 years
19
  35.2%
19
  35.8%
38
  35.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
Female
32
  59.3%
27
  50.9%
59
  55.1%
Male
22
  40.7%
26
  49.1%
48
  44.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 54 participants 53 participants 107 participants
Canada 17 16 33
United States 37 37 74
Patients with mild and moderate hyperpigmentation  
Measure Type: Number
Unit of measure:  Number of patients
 Number Analyzed 54 participants 53 participants 107 participants
No hyperpigmentation 39 34 73
Mild hyperpigmentation 5 10 15
Moderate hyperpigmentation 8 8 16
Severe hyperpigmentation 2 1 3
Investigator Global Assessment (IGA) Score  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 54 participants 53 participants 107 participants
IGA 3 (Moderate acne) 44 45 89
IGA 4 (Severe acne) 10 8 18
Fitzpatrick Skin type   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 54 participants 53 participants 107 participants
Skin type I 5 6 11
Skin type II 14 15 29
Skin type III 24 21 45
Skin type IV 4 6 10
Skin type V 5 2 7
Skin type VI 2 3 5
[1]
Measure Description: 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 V: Dark brown; Middle Eastern skin types Very rarely burns, tans very easily VI: Black Never burns, tans very easily
Scarring   [1] 
Measure Type: Number
Unit of measure:  Number of patients
 Number Analyzed 54 participants 53 participants 107 participants
Patients with no scarring 21 26 47
Patients with almost clear scarring 9 10 19
Patients with mild scarring 15 9 24
Patients with moderate scarring 6 6 12
Patients with severe scarring 3 1 4
Patients with very severe scarring 0 1 1
[1]
Measure Description:

The investigator assess the scarring using a scale called SCAR-S. Clear 0: No visible scars from acne. Almost clear 1: Hardly visible scars from 2.5 meters away. Mild 2: Easily recognizable, less than ½ the affected area (eg. face, back or chest) involved.

Moderate 3: More than ½ affected area (eg. face, back or chest) involved. Severe 4: Entire area involved. Very severe 5: Entire area with prominent atrophic or hypertrophic scars.
Patients with dryness   [1] 
Measure Type: Number
Unit of measure:  Number of patients
 Number Analyzed 54 participants 53 participants 107 participants
No dryness 45 46 91
Mild dryness 9 7 16
[1]
Measure Description: The investigator assess the dryness using a scale from 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe).
1.Primary Outcome
Title Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.
Hide Description [Not Specified]
Time Frame 12 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.26
(1.53 to 16.99)
1.89
(0.00 to 5.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Visonac Cream With PDT, Vehicle Cream With 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 0.0703
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 Odds Ratio (OR)
Estimated Value 6.43
Confidence Interval (2-Sided) 95%
0.65 to 63.18
Estimation Comments [Not Specified]
2.Primary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)
Hide Description [Not Specified]
Time Frame 12 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: lesions
-14.0  (17.94) -13.8  (23.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Visonac Cream With PDT, Vehicle Cream With 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 0.2969
Comments Priori threshold for statistical significance was 5%
Method ANCOVA
Comments ANCOVA model, including center and baseline lesion count as a covariates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.92
Confidence Interval (2-Sided) 95%
-11.35 to 3.50
Estimation Comments [Not Specified]
3.Primary Outcome
Title Absolute Change From Baseline in Facial Non Inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: lesions
-14.3  (26.54) -17.1  (25.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Visonac Cream With PDT, Vehicle Cream With 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 0.8913
Comments Priori threshold for statistical significance was 5%
Method ANCOVA
Comments ANCOVA model, including center and baseline lesion count as a covariates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
-9.09 to 10.43
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Hide Description [Not Specified]
Time Frame 6 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-35.4  (30.85) -20.3  (38.72)
5.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Hide Description [Not Specified]
Time Frame 12 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
-33.1  (39.34) -27.5  (44.38)
6.Secondary Outcome
Title Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame 6 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
-25.3  (39.72) -15.8  (47.11)
7.Secondary Outcome
Title Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
-26.0  (52.23) -24.4  (37.66)
8.Secondary Outcome
Title Percent Change From Baseline in Facial Total Lesion Count
Hide Description [Not Specified]
Time Frame 6 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
-29.5  (27.72) -18.0  (35.39)
9.Secondary Outcome
Title Percent Change From Baseline in Facial Total Lesion Count
Hide Description [Not Specified]
Time Frame 12 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
-29.8  (36.04) -26.8  (29.61)
10.Secondary Outcome
Title Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame 12 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Measure Type: Number
Unit of Measure: participants
17 10
11.Secondary Outcome
Title Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline
Hide Description [Not Specified]
Time Frame 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Measure Type: Number
Unit of Measure: participants
20 19
12.Secondary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame 6 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: lesions
-17.5  (9.0) -10.8  (22.41)
13.Secondary Outcome
Title Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame 6 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: lesions
12.9  (21.41) 11.3  (28.24)
14.Secondary Outcome
Title Absolute Change From Baseline in Facial Total Lesion Count
Hide Description [Not Specified]
Time Frame 6 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: lesions
-27.2  (26.19) -20.6  (36.68)
15.Secondary Outcome
Title Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.
Hide Description [Not Specified]
Time Frame 6 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 52 52
Measure Type: Number
Unit of Measure: Participants
3 1
16.Secondary Outcome
Title Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Hide Description Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Time Frame directly after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 53
Mean (Full Range)
Unit of Measure: cm
1.5
(0.0 to 9.8)
0.28
(0.0 to 3.6)
17.Secondary Outcome
Title Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Hide Description Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Time Frame directly after second treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 52 52
Mean (Full Range)
Unit of Measure: cm
1.37
(0.0 to 8.5)
0.15
(0.0 to 1.6)
18.Secondary Outcome
Title Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Hide Description Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Time Frame directly after third treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 51 50
Mean (Full Range)
Unit of Measure: cm
1.53
(0.0 to 8.1)
0.17
(0.0 to 1.4)
19.Secondary Outcome
Title Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Hide Description Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Time Frame directly after fourth treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 51 49
Mean (Full Range)
Unit of Measure: cm
1.39
(0.0 to 8.2)
0.19
(0.0 to 2.6)
20.Secondary Outcome
Title Proportion of Patients With Mild and Moderate Hyperpigmentation
Hide Description [Not Specified]
Time Frame at 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: participants
26 32
21.Secondary Outcome
Title Proportion of Patients With Severe Hyperpigmentation
Hide Description [Not Specified]
Time Frame at 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: participants
1 0
22.Secondary Outcome
Title Proportion of Patients With Mild or Moderate Scarring at End of Study
Hide Description [Not Specified]
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: participants
36 34
23.Secondary Outcome
Title Proportion of Patients With Clear or Almost Clear Scarring at End of Study
Hide Description [Not Specified]
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: participants
59 63
24.Secondary Outcome
Title Proportion of Patients With Severe and Very Severe Scarring at End of Study
Hide Description [Not Specified]
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: participants
6 2
25.Secondary Outcome
Title Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)
Hide Description [Not Specified]
Time Frame at 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: participants
0 0
26.Secondary Outcome
Title Proportion of Patients With Dryness (Mild)
Hide Description [Not Specified]
Time Frame at 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:
Active treatment, Light dose 37 J/cm2.
Placebo treatment, Light dose 37 J/cm2.
Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: participants
20 16
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description Active treatment, Light dose 37 J/cm2. Placebo treatment, Light dose 37 J/cm2.
All-Cause Mortality
Visonac Cream With PDT Vehicle Cream With PDT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Visonac Cream With PDT Vehicle Cream With PDT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.8%
Visonac Cream With PDT Vehicle Cream With PDT
Affected / at Risk (%) Affected / at Risk (%)
Total   46/54 (85.19%)   32/53 (60.38%) 
General disorders     
Pain  27/54 (50.00%)  6/53 (11.32%) 
Facial pain  4/54 (7.41%)  4/53 (7.55%) 
Feeling hot  2/54 (3.70%)  2/53 (3.77%) 
Infections and infestations     
Nasopharyngitis  10/54 (18.52%)  5/53 (9.43%) 
Nervous system disorders     
Paraestehesia  9/54 (16.67%)  1/53 (1.89%) 
Skin and subcutaneous tissue disorders     
Erythema  26/54 (48.15%)  9/53 (16.98%) 
Pruritus  14/54 (25.93%)  8/53 (15.09%) 
Skin burning sensation  12/54 (22.22%)  4/53 (7.55%) 
Skin irritation  4/54 (7.41%)  0/53 (0.00%) 
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Project director Per Fuglerud
Organization: Photocure
Phone: +47 22 06 16 54
EMail: pf@photocure.no
Layout table for additonal information
Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT00933543     History of Changes
Other Study ID Numbers: PC TA204/09
First Submitted: July 2, 2009
First Posted: July 7, 2009
Results First Submitted: March 14, 2013
Results First Posted: November 15, 2013
Last Update Posted: December 11, 2013