The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
26
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
CLINICAL TESTING CENTER of BEVERLY HILLS
Beverly Hills, California, United States
Time to Complete Wound Closure (Epithelialization)
Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. 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.
Time frame: Over the course of 1 month following the initial treatment.
Cosmesis/11-point Likert Scale
The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).
Time frame: At 1 month following the initial treatment.
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