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A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris

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: NCT01347879
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : January 16, 2014
Last Update Posted : January 16, 2014
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
Drug: Vehicle cream with PDT
Enrollment 153
Recruitment Details Dermatology clinics in the US.
Pre-assignment Details  
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37 J/cm2

Visonac photodynamic therapy (PDT): cream application prior to illumination with red light

Period Title: Overall Study
Started 53 100
Completed 46 83
Not Completed 7 17
Reason Not Completed
Adverse Event             0             12
Lost to Follow-up             2             0
Withdrawal by Subject             3             2
Other             2             3
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT Total
Hide Arm/Group Description

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Total of all reporting groups
Overall Number of Baseline Participants 53 100 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 100 participants 153 participants
<=18 years
35
  66.0%
59
  59.0%
94
  61.4%
Between 18 and 65 years
18
  34.0%
41
  41.0%
59
  38.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 100 participants 153 participants
18.6  (5.8) 18.6  (5.5) 18.6  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 100 participants 153 participants
Female
22
  41.5%
44
  44.0%
66
  43.1%
Male
31
  58.5%
56
  56.0%
87
  56.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 100 participants 153 participants
53 100 153
Skin type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 100 participants 153 participants
Skin type I 0 1 1
Skin type II 24 34 58
Skin type III 15 38 53
Skin type IV 7 15 22
Skin type V 6 8 14
Skin type VI 1 4 5
[1]
Measure Description:

Fitzpatrick skin type. The Fitzpatrick Scale:

Type I (scores 0–7) Light, pale white. Always burns, never tans

Type II (scores 8–16) White; fair. Usually burns, tans with difficulty

Type III (scores 17–24) Medium, white to olive. Sometimes mild burn, gradually tans to olive.

Type IV (scores 25–30) Olive, moderate brown. Rarely burns, tans with ease to a moderate brown.

Type V (scores over 30) Brown, dark brown. Very rarely burns, tans very easily

Type VI Black, very dark brown to black. Never burns, tans very easily, deeply pigmented.

1.Primary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
Hide Description [Not Specified]
Time Frame From baseline to 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 100
Mean (Standard Deviation)
Unit of Measure: lesion count
-7.8  (21.4) -15.6  (16.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream With PDT, Visonac Cream With PDT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments Lesion count at baseline and center as covariates
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -7.35
Confidence Interval (2-Sided) 95%
-12.5 to -2.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
Hide Description [Not Specified]
Time Frame From baseline to 12 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 100
Mean (Standard Deviation)
Unit of Measure: lesion count
-10.7  (22.1) -11.8  (19.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream With PDT, Visonac Cream With PDT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8527
Comments [Not Specified]
Method ANCOVA
Comments Lesion count at baseline and center as covariates
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-6.6 to 5.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.
Hide Description [Not Specified]
Time Frame From baseline to 12 weeks after the first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 100
Median (Full Range)
Unit of Measure: percent change
-26.6
(-100 to 176)
-43.8
(-100 to 84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream With PDT, Visonac Cream With PDT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method ANCOVA
Comments Lesion count at baseline and center as covariates
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -20.0
Confidence Interval (2-Sided) 95%
-33.2 to -6.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.
Hide Description One Investigator Global Assessment (IGA) scale was used including inflammatory and non-inflammatory lesions. The investigator qualitatively graded the overall acne severity on a scale from 0 to 4, with 4 being the most severe. Success was defined as an improvement of at least 2 grades from the baseline score.
Time Frame From baseline to 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 100
Measure Type: Number
Unit of Measure: participants
14 44
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream With PDT, Visonac Cream With PDT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0125
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
5.Secondary Outcome
Title Pain During Illumination.
Hide Description Pain during illumination was assessed by patient using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Time Frame Immediately after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 100
Mean (Full Range)
Unit of Measure: VAS score in cm
0.52
(0.0 to 3.6)
3.38
(0.0 to 8.8)
6.Secondary Outcome
Title Number of Patients With Adverse Events.
Hide Description [Not Specified]
Time Frame From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 100
Measure Type: Number
Unit of Measure: participants
14 48
7.Secondary Outcome
Title Erythema Score of Mild and Moderate
Hide Description Clinical assessment using a 4 point scale; none, mild, moderate, severe
Time Frame Immediately after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 100
Measure Type: Number
Unit of Measure: participants
37 86
8.Secondary Outcome
Title Clear and Almost Clear Scarring According to Scarring Score
Hide Description Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Time Frame at week 12 after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 46 91
Measure Type: Number
Unit of Measure: participants
25 53
9.Secondary Outcome
Title Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
Hide Description [Not Specified]
Time Frame From baseline to 12 weeks after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 100
Median (Full Range)
Unit of Measure: percent change
-37.0
(-100 to 196)
-31.0
(-100 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Cream With PDT, Visonac Cream With PDT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7161
Comments [Not Specified]
Method ANCOVA
Comments Lesion count at baseline and center as covariate
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -2.56
Confidence Interval (2-Sided) 95%
-16.5 to 11.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Erythema Score of Severe
Hide Description Clinical assessment using a 4 point scale; none, mild, moderate, severe
Time Frame Immediately after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 100
Measure Type: Number
Unit of Measure: participants
0 3
11.Secondary Outcome
Title Erythema Score of Mild and Moderate
Hide Description Clinical assessment using a 4 point scale; none, mild, moderate, severe
Time Frame 2 days after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 95
Measure Type: Number
Unit of Measure: participants
26 65
12.Secondary Outcome
Title Erythema Score of Severe
Hide Description Clinical assessment using a 4 point scale; none, mild, moderate, severe
Time Frame 2 days after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 53 95
Measure Type: Number
Unit of Measure: participants
0 0
13.Secondary Outcome
Title Mild and Moderate Scarring According to Scarring Score
Hide Description Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Time Frame at week 12 after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 46 91
Measure Type: Number
Unit of Measure: participants
21 38
14.Secondary Outcome
Title Severe and Very Severe Scarring According to Scarring Score
Hide Description Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Time Frame at week 12 after first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description:

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

Overall Number of Participants Analyzed 46 91
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vehicle Cream With PDT Visonac Cream With PDT
Hide Arm/Group Description

Placebo treatment, Light dose 37 J/cm2

Visonac PDT : cream application prior to illumination with red light

active treatment with light dose of 37J/cm2

Visonac PDT : cream application prior to illumination with red light

All-Cause Mortality
Vehicle Cream With PDT Visonac Cream With PDT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vehicle Cream With PDT Visonac Cream With PDT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Vehicle Cream With PDT Visonac Cream With PDT
Affected / at Risk (%) Affected / at Risk (%)
Total   14/53 (26.42%)   48/100 (48.00%) 
Eye disorders     
Conjunctivitis bacterial  0/53 (0.00%)  1/100 (1.00%) 
Gastrointestinal disorders     
Nausea  0/53 (0.00%)  3/100 (3.00%) 
General disorders     
Tooth abscess  1/53 (1.89%)  0/100 (0.00%) 
Vomiting  0/53 (0.00%)  2/100 (2.00%) 
Pyrexia  0/53 (0.00%)  2/100 (2.00%) 
Infections and infestations     
Staphylococcal infection  1/53 (1.89%)  0/100 (0.00%) 
Gastroenteritis  0/53 (0.00%)  2/100 (2.00%) 
Nasopharyngitis  0/53 (0.00%)  2/100 (2.00%) 
Injury, poisoning and procedural complications     
Concussion  1/53 (1.89%)  1/100 (1.00%) 
Joint sprain  0/53 (0.00%)  2/100 (2.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  0/53 (0.00%)  2/100 (2.00%) 
Nervous system disorders     
Headache  3/53 (5.66%)  3/100 (3.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  2/53 (3.77%)  0/100 (0.00%) 
Cough  1/53 (1.89%)  0/100 (0.00%) 
Cough  1/53 (1.89%)  1/100 (1.00%) 
Skin and subcutaneous tissue disorders     
Pain of skin  0/53 (0.00%)  17/100 (17.00%) 
Skin burning sensation  0/53 (0.00%)  15/100 (15.00%) 
Pruritus  1/53 (1.89%)  8/100 (8.00%) 
Erythema  0/53 (0.00%)  4/100 (4.00%) 
Rash  1/53 (1.89%)  2/100 (2.00%) 
Scab  0/53 (0.00%)  2/100 (2.00%) 
Swelling face  1/53 (1.89%)  1/100 (1.00%) 
Dermatitis  1/53 (1.89%)  0/100 (0.00%) 
Skin hyperpigmentation  0/53 (0.00%)  2/100 (2.00%) 
Blister  0/53 (0.00%)  1/100 (1.00%) 
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
Name/Title: Dr David Pariser
Organization: Virginia Clinical Research, Inc.
Phone: 757-625-0151
Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT01347879     History of Changes
Other Study ID Numbers: PCTA206/11
First Submitted: May 3, 2011
First Posted: May 4, 2011
Results First Submitted: September 23, 2013
Results First Posted: January 16, 2014
Last Update Posted: January 16, 2014