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Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients

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ClinicalTrials.gov Identifier: NCT01160848
Recruitment Status : Completed
First Posted : July 12, 2010
Results First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Photocure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Acne Vulgaris
Interventions Drug: Area cleaned with saline water and occluded with Tegaderm
Drug: Area cleaned with saline water
Drug: Area cleaned with Ethyl alcohol solution
Drug: Visonac left on the skin for 24 hours in facial area one
Drug: Visonac wiped off after one hour
Drug: Visonac left on the skin 24 hours in facial area two
Enrollment 20
Recruitment Details

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

Pre-assignment Details  
Arm/Group Title 3 Areas Per Patient, 3 Hours 3 Areas Per Patient, 24 Hours
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 12 8
Completed 12 8
Not Completed 0 0
Arm/Group Title 3 Areas Per Patient, 3 Hours 3 Areas Per Patient, 24 Hours Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 12 8 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 8 participants 20 participants
<=18 years
7
  58.3%
8
 100.0%
15
  75.0%
Between 18 and 65 years
5
  41.7%
0
   0.0%
5
  25.0%
>=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 12 participants 8 participants 20 participants
Female
4
  33.3%
3
  37.5%
7
  35.0%
Male
8
  66.7%
5
  62.5%
13
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 8 participants 20 participants
12 8 20
Fluoresence intensity   [1] 
Mean (Full Range)
Unit of measure:  Fluoresence intensity unit
Number Analyzed 12 participants 8 participants 20 participants
Alcohol wipe and Visonac without occlusion
10.5
(4 to 17.5)
NA [2] 
(NA to NA)
10.5
(4 to 17.5)
Saline wipe and Visonac with occlusion
11.2
(5 to 28)
NA [2] 
(NA to NA)
11.2
(5 to 28)
Saline wipe and Visonac without occlusion
10.8
(5 to 17)
NA [2] 
(NA to NA)
10.8
(5 to 17)
Visonac left on skin for 1 hour
NA [2] 
(NA to NA)
9.3
(3 to 20.5)
9.3
(3 to 20.5)
Visonac left on skin for 24 hours, area 1
NA [2] 
(NA to NA)
10.5
(4 to 19.5)
10.5
(4 to 19.5)
Visonac left on skin for 24 hours, area 2
NA [2] 
(NA to NA)
10.6
(4 to 21)
10.6
(4 to 21)
[1]
Measure Description:

In the study arm "3 Areas Per Patient, 3 Hours", participants were only treated with "Alcohol wipe and Visonac without occlusion", "Saline wipe and Visonac with occlusion", "Saline wipe and Visonac without occlusion".

In the study arm "3 Areas Per Patient, 24 Hours" participants were only treated with "Visonac left on skin for 1 hour", "Visonac left on skin for 24 hours, area 1", "Visonac left on skin for 24 hours, area 2".

[2]
Participants in this study arm were not provided this treatment, please see Baseline Measure Description.
1.Primary Outcome
Title Photoactive Porphyrins Level
Hide Description Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Time Frame 1.5 hours after cream application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1: Area Cleaned With Saline and Occluded With Tegaderm Area Cleaned With Saline Area Cleaned With Ethyl Alcohol Solution
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 12 12
Mean (95% Confidence Interval)
Unit of Measure: Fluorescence intensity unit
33.0
(24.8 to 41.3)
24.8
(20.4 to 29.1)
19.7
(15.2 to 24.1)
2.Primary Outcome
Title Photoactive Porphyrins Level
Hide Description Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Time Frame 3 hours after cream application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1: Area Cleaned With Saline and Occluded With Tegaderm Area Cleaned With Saline Area Cleaned With Ethyl Alcohol Solution
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 12 12
Mean (95% Confidence Interval)
Unit of Measure: Fluorescence intensity unit
59.3
(45.4 to 73.2)
38.3
(31.6 to 45.1)
30.1
(23.2 to 37.0)
3.Primary Outcome
Title Photoactive Porphyrins Level
Hide Description Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Time Frame 3 hours after cream application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visonac Wiped Off After 1 Hour Visonac Left on Skin for 24 Hours in Area 1 Visonac Left on Skin for 24 Hours in Area 2
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 8 8
Mean (95% Confidence Interval)
Unit of Measure: Fluorescence intensity unit
35.3
(16.4 to 54.1)
33.5
(20.4 to 46.6)
37.3
(21.4 to 53.1)
4.Primary Outcome
Title Photoactive Porphyrins Level
Hide Description Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Time Frame 8 hours after cream application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visonac Wiped Off After 1 Hour Visonac Left on Skin for 24 Hours in Area 1 Visonac Left on Skin for 24 Hours in Area 2
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 8 8
Mean (95% Confidence Interval)
Unit of Measure: Fluorescence intensity unit
21.6
(12.4 to 30.8)
38.2
(23.1 to 53.3)
44.3
(24.6 to 64.1)
5.Primary Outcome
Title Photoactive Porphyrins Level
Hide Description Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Time Frame 12 hours after cream application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visonac Wiped Off After 1 Hour Visonac Left on Skin for 24 Hours in Area 1 Visonac Left on Skin for 24 Hours in Area 2
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 8 8
Mean (95% Confidence Interval)
Unit of Measure: Fluorescence intensity unit
16.8
(11.8 to 21.8)
33.9
(23.5 to 44.4)
38.1
(21.8 to 54.5)
6.Primary Outcome
Title Photoactive Porphyrins Level
Hide Description Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Time Frame 24 hours after cream application
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visonac Wiped Off After 1 Hour Visonac Left on Skin for 24 Hours in Area 1 Visonac Left on Skin for 24 Hours in Area 2
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 8 8
Mean (95% Confidence Interval)
Unit of Measure: Fluorescence intensity unit
13.1
(8.5 to 17.7)
25.8
(17.0 to 34.6)
25.9
(17.6 to 34.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3 Areas Per Patient, 3 Hours 3 Areas Per Patient, 24 Hours
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
3 Areas Per Patient, 3 Hours 3 Areas Per Patient, 24 Hours
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
3 Areas Per Patient, 3 Hours 3 Areas Per Patient, 24 Hours
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3 Areas Per Patient, 3 Hours 3 Areas Per Patient, 24 Hours
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/12 (41.67%)      4/8 (50.00%)    
Skin and subcutaneous tissue disorders     
Itching  3/12 (25.00%)  3 4/8 (50.00%)  4
Erythema  4/12 (33.33%)  5 2/8 (25.00%)  4
Increased number of pimples  1/12 (8.33%)  1 1/8 (12.50%)  1
Burning  0/12 (0.00%)  0 1/8 (12.50%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Organization: Photocure ASA
Phone: +47 22062210
EMail: pf@photocure.no
Layout table for additonal information
Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT01160848     History of Changes
Other Study ID Numbers: PC TA205/10
First Submitted: July 8, 2010
First Posted: July 12, 2010
Results First Submitted: October 22, 2013
Results First Posted: May 20, 2014
Last Update Posted: May 20, 2014