Trial Outcomes & Findings for A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris (NCT NCT01347879)
NCT ID: NCT01347879
Last Updated: 2014-01-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
From baseline to 12 weeks after first treatment
Results posted on
2014-01-16
Participant Flow
Dermatology clinics in the US.
Participant milestones
| Measure |
Visonac Cream With PDT
active treatment with light dose of 37 J/cm2
Visonac photodynamic therapy (PDT): cream application prior to illumination with red light
|
Vehicle Cream With PDT
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
53
|
|
Overall Study
COMPLETED
|
83
|
46
|
|
Overall Study
NOT COMPLETED
|
17
|
7
|
Reasons for withdrawal
| Measure |
Visonac Cream With PDT
active treatment with light dose of 37 J/cm2
Visonac photodynamic therapy (PDT): cream application prior to illumination with red light
|
Vehicle Cream With PDT
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Other
|
3
|
2
|
Baseline Characteristics
A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
18.6 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
18.6 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
18.6 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
100 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Skin type
Skin type I
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Skin type
Skin type II
|
24 participants
n=5 Participants
|
34 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Skin type
Skin type III
|
15 participants
n=5 Participants
|
38 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Skin type
Skin type IV
|
7 participants
n=5 Participants
|
15 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Skin type
Skin type V
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Skin type
Skin type VI
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 12 weeks after first treatmentOutcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
|
-7.8 lesion count
Standard Deviation 21.4
|
-15.6 lesion count
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: From baseline to 12 weeks after the first treatmentOutcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
|
-10.7 lesion count
Standard Deviation 22.1
|
-11.8 lesion count
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: From baseline to 12 weeks after the first treatmentOutcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.
|
-26.6 percent change
Interval -100.0 to 176.0
|
-43.8 percent change
Interval -100.0 to 84.0
|
SECONDARY outcome
Timeframe: From baseline to 12 weeks after first treatmentOne 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.
Outcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.
|
14 participants
|
44 participants
|
SECONDARY outcome
Timeframe: Immediately after first treatmentPain 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.
Outcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Pain During Illumination.
|
0.52 VAS score in cm
Interval 0.0 to 3.6
|
3.38 VAS score in cm
Interval 0.0 to 8.8
|
SECONDARY outcome
Timeframe: From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administrationOutcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Number of Patients With Adverse Events.
|
14 participants
|
48 participants
|
SECONDARY outcome
Timeframe: Immediately after first treatmentClinical assessment using a 4 point scale; none, mild, moderate, severe
Outcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Erythema Score of Mild and Moderate
|
37 participants
|
86 participants
|
SECONDARY outcome
Timeframe: at week 12 after first treatmentPopulation: 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.
Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Outcome measures
| Measure |
Vehicle Cream With PDT
n=46 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=91 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Clear and Almost Clear Scarring According to Scarring Score
|
25 participants
|
53 participants
|
SECONDARY outcome
Timeframe: From baseline to 12 weeks after first treatmentOutcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
|
-37.0 percent change
Interval -100.0 to 196.0
|
-31.0 percent change
Interval -100.0 to 100.0
|
SECONDARY outcome
Timeframe: Immediately after first treatmentClinical assessment using a 4 point scale; none, mild, moderate, severe
Outcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Erythema Score of Severe
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 2 days after first treatmentPopulation: 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.
Clinical assessment using a 4 point scale; none, mild, moderate, severe
Outcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=95 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Erythema Score of Mild and Moderate
|
26 participants
|
65 participants
|
SECONDARY outcome
Timeframe: 2 days after first treatmentPopulation: 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.
Clinical assessment using a 4 point scale; none, mild, moderate, severe
Outcome measures
| Measure |
Vehicle Cream With PDT
n=53 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=95 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Erythema Score of Severe
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at week 12 after first treatmentPopulation: 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.
Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Outcome measures
| Measure |
Vehicle Cream With PDT
n=46 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=91 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Mild and Moderate Scarring According to Scarring Score
|
21 participants
|
38 participants
|
SECONDARY outcome
Timeframe: at week 12 after first treatmentPopulation: 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.
Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Outcome measures
| Measure |
Vehicle Cream With PDT
n=46 Participants
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=91 Participants
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Severe and Very Severe Scarring According to Scarring Score
|
0 participants
|
0 participants
|
Adverse Events
Vehicle Cream With PDT
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Visonac Cream With PDT
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vehicle Cream With PDT
n=53 participants at risk
Placebo treatment, Light dose 37 J/cm2
Visonac PDT : cream application prior to illumination with red light
|
Visonac Cream With PDT
n=100 participants at risk
active treatment with light dose of 37J/cm2
Visonac PDT : cream application prior to illumination with red light
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/53
|
17.0%
17/100
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/53
|
15.0%
15/100
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/53
|
8.0%
8/100
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/53
|
4.0%
4/100
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/53
|
2.0%
2/100
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/53
|
2.0%
2/100
|
|
Nervous system disorders
Headache
|
5.7%
3/53
|
3.0%
3/100
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
2/53
|
0.00%
0/100
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.9%
1/53
|
1.0%
1/100
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.9%
1/53
|
0.00%
0/100
|
|
Eye disorders
Conjunctivitis bacterial
|
0.00%
0/53
|
1.0%
1/100
|
|
Infections and infestations
Staphylococcal infection
|
1.9%
1/53
|
0.00%
0/100
|
|
General disorders
Tooth abscess
|
1.9%
1/53
|
0.00%
0/100
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/53
|
1.0%
1/100
|
|
Injury, poisoning and procedural complications
Concussion
|
1.9%
1/53
|
1.0%
1/100
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/53
|
2.0%
2/100
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/53
|
1.0%
1/100
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/53
|
2.0%
2/100
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/53
|
2.0%
2/100
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/53
|
3.0%
3/100
|
|
General disorders
Vomiting
|
0.00%
0/53
|
2.0%
2/100
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/53
|
2.0%
2/100
|
|
General disorders
Pyrexia
|
0.00%
0/53
|
2.0%
2/100
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/53
|
2.0%
2/100
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60