Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation
|ClinicalTrials.gov Identifier: NCT00656474|
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : July 25, 2011
Last Update Posted : July 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Wounds||Drug: Placebo gel Drug: GLYC-101 gel (1.0 %)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-blind, Randomized, Placebo-controlled Phase 2 Pilot Study to Investigate the Safety and Clinical Outcomes of 1.0 % Topically Applied GLYC-101, Compared to Placebo, in Healthy Subjects Undergoing Retro-auricular Carbon Dioxide Laser Skin Resurfacing.|
|Study Start Date :||March 2008|
|Primary Completion Date :||April 2008|
|Study Completion Date :||August 2008|
GLYC-101 Active Retro-auricular Site (1 per participant)
Drug: GLYC-101 gel (1.0 %)
Administration on Day 1, 3 and 5 post laser ablation.
Placebo Comparator: 2 Comparator
Placebo Retro-auricular Site (1 per participant)
This arm undergoes laser ablation with subsequent Placebo gel administration
Drug: Placebo gel
Administration of Placebo gel on Day 1, 3 and 5 post ablation.
- Time to Complete Wound Closure (Epithelialization) [ Time Frame: Over the course of 1 month following the initial treatment. ]Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.
- Percentage of Wound Epithelialized [ Time Frame: Day 15 post laser ablation. ]The percentage of wound epithelialized was assessed at Day 15 post laser ablation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656474
|United States, California|
|CLINICAL TESTING CENTER of BEVERLY HILLS|
|Beverly Hills, California, United States, 90210|
|Principal Investigator:||John Joseph, MD||CLINICAL TESTING CENTER of BEVERLY HILLS|