Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation
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|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|
|Actual Primary Completion Date :||April 2008|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|