Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Time to Complete Wound Closure (Epithelialization) [ Time Frame: Over the course of 1 month following the initial treatment. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]The percentage of wound epithelialized was assessed at Day 15 post laser ablation.
|Study Start Date:||March 2008|
|Study Completion Date:||August 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
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.
The proposed pilot-study will document feasibility, safety and efficacy of topically applied Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent over the course of 1 month following the treatment. as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2 Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101 compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).
|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|