Trial Outcomes & Findings for Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients (NCT NCT01160848)
NCT ID: NCT01160848
Last Updated: 2014-05-20
Results Overview
Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
1.5 hours after cream application
Results posted on
2014-05-20
Participant Flow
The study was conducted in one center in the US: Michael Jarratt M.D. DermResearch Inc. 8140 N Mopac Building 3, Suite 120 Austin, TX 78759. First patient entered the study on the 8th of November 2010 Last patient last visit on the 9th January 2011
Participant milestones
| Measure |
3 Areas Per Patient, 3 Hours
Visonac : MAL 80 mg/g Group 1: Alcohol wipe and Visonac without occlusion Group 2: Saline wipe and Visonac with occlusion Group 3: Saline wipe and Visonac without occlusion
|
3 Areas Per Patient, 24 Hours
Group 1: Visonac left on skin for 1 hour Group 2: Visonac left on skin for 24 hours, area 1 Group 3: Visonac left on skin for 24 hours, area 2
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
|
Overall Study
COMPLETED
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients
Baseline characteristics by cohort
| Measure |
3 Areas Per Patient, 3 Hours
n=12 Participants
|
3 Areas Per Patient, 24 Hours
n=8 Participants
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Fluoresence intensity
Alcohol wipe and Visonac without occlusion
|
10.5 Fluoresence intensity unit
FULL_RANGE 5.0 • n=5 Participants
|
NA Fluoresence intensity unit
n=7 Participants
|
10.5 Fluoresence intensity unit
n=5 Participants
|
|
Fluoresence intensity
Saline wipe and Visonac with occlusion
|
11.2 Fluoresence intensity unit
n=5 Participants
|
NA Fluoresence intensity unit
n=7 Participants
|
11.2 Fluoresence intensity unit
n=5 Participants
|
|
Fluoresence intensity
Saline wipe and Visonac without occlusion
|
10.8 Fluoresence intensity unit
n=5 Participants
|
NA Fluoresence intensity unit
n=7 Participants
|
10.8 Fluoresence intensity unit
n=5 Participants
|
|
Fluoresence intensity
Visonac left on skin for 1 hour
|
NA Fluoresence intensity unit
n=5 Participants
|
9.3 Fluoresence intensity unit
n=7 Participants
|
9.3 Fluoresence intensity unit
n=5 Participants
|
|
Fluoresence intensity
Visonac left on skin for 24 hours, area 1
|
NA Fluoresence intensity unit
n=5 Participants
|
10.5 Fluoresence intensity unit
n=7 Participants
|
10.5 Fluoresence intensity unit
n=5 Participants
|
|
Fluoresence intensity
Visonac left on skin for 24 hours, area 2
|
NA Fluoresence intensity unit
n=5 Participants
|
10.6 Fluoresence intensity unit
n=7 Participants
|
10.6 Fluoresence intensity unit
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.5 hours after cream applicationPhotoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Outcome measures
| Measure |
Part 1: Area Cleaned With Saline and Occluded With Tegaderm
n=12 Participants
|
Area Cleaned With Saline
n=12 Participants
|
Area Cleaned With Ethyl Alcohol Solution
n=12 Participants
|
|---|---|---|---|
|
Photoactive Porphyrins Level
|
33.0 Fluorescence intensity unit
Interval 24.8 to 41.3
|
24.8 Fluorescence intensity unit
Interval 20.4 to 29.1
|
19.7 Fluorescence intensity unit
Interval 15.2 to 24.1
|
PRIMARY outcome
Timeframe: 3 hours after cream applicationPhotoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Outcome measures
| Measure |
Part 1: Area Cleaned With Saline and Occluded With Tegaderm
n=12 Participants
|
Area Cleaned With Saline
n=12 Participants
|
Area Cleaned With Ethyl Alcohol Solution
n=12 Participants
|
|---|---|---|---|
|
Photoactive Porphyrins Level
|
59.3 Fluorescence intensity unit
Interval 45.4 to 73.2
|
38.3 Fluorescence intensity unit
Interval 31.6 to 45.1
|
30.1 Fluorescence intensity unit
Interval 23.2 to 37.0
|
PRIMARY outcome
Timeframe: 3 hours after cream applicationPhotoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Outcome measures
| Measure |
Part 1: Area Cleaned With Saline and Occluded With Tegaderm
n=8 Participants
|
Area Cleaned With Saline
n=8 Participants
|
Area Cleaned With Ethyl Alcohol Solution
n=8 Participants
|
|---|---|---|---|
|
Photoactive Porphyrins Level
|
35.3 Fluorescence intensity unit
Interval 16.4 to 54.1
|
33.5 Fluorescence intensity unit
Interval 20.4 to 46.6
|
37.3 Fluorescence intensity unit
Interval 21.4 to 53.1
|
PRIMARY outcome
Timeframe: 8 hours after cream applicationPhotoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Outcome measures
| Measure |
Part 1: Area Cleaned With Saline and Occluded With Tegaderm
n=8 Participants
|
Area Cleaned With Saline
n=8 Participants
|
Area Cleaned With Ethyl Alcohol Solution
n=8 Participants
|
|---|---|---|---|
|
Photoactive Porphyrins Level
|
21.6 Fluorescence intensity unit
Interval 12.4 to 30.8
|
38.2 Fluorescence intensity unit
Interval 23.1 to 53.3
|
44.3 Fluorescence intensity unit
Interval 24.6 to 64.1
|
PRIMARY outcome
Timeframe: 12 hours after cream applicationPhotoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Outcome measures
| Measure |
Part 1: Area Cleaned With Saline and Occluded With Tegaderm
n=8 Participants
|
Area Cleaned With Saline
n=8 Participants
|
Area Cleaned With Ethyl Alcohol Solution
n=8 Participants
|
|---|---|---|---|
|
Photoactive Porphyrins Level
|
16.8 Fluorescence intensity unit
Interval 11.8 to 21.8
|
33.9 Fluorescence intensity unit
Interval 23.5 to 44.4
|
38.1 Fluorescence intensity unit
Interval 21.8 to 54.5
|
PRIMARY outcome
Timeframe: 24 hours after cream applicationPhotoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Outcome measures
| Measure |
Part 1: Area Cleaned With Saline and Occluded With Tegaderm
n=8 Participants
|
Area Cleaned With Saline
n=8 Participants
|
Area Cleaned With Ethyl Alcohol Solution
n=8 Participants
|
|---|---|---|---|
|
Photoactive Porphyrins Level
|
13.1 Fluorescence intensity unit
Interval 8.5 to 17.7
|
25.8 Fluorescence intensity unit
Interval 17.0 to 34.6
|
25.9 Fluorescence intensity unit
Interval 17.6 to 34.2
|
Adverse Events
3 Areas Per Patient, 3 Hours
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
3 Areas Per Patient, 24 Hours
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3 Areas Per Patient, 3 Hours
n=12 participants at risk
|
3 Areas Per Patient, 24 Hours
n=8 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching
|
25.0%
3/12 • Number of events 3
|
50.0%
4/8 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
4/12 • Number of events 5
|
25.0%
2/8 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Increased number of pimples
|
8.3%
1/12 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Burning
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place