NCT00792688

Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation

Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Investigate the Safety and Efficacy of 0.1% and 1.0% Topically Applied GLYC-101, Compared to Placebo, in Patients Undergoing Carbon Dioxide Laser Skin Resurfacing of the Lower Eyelids.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: TR Therapeutics · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Wounds

Interventions

Type	Name	Description
DRUG	GLYC-101 Gel (0.1%)	Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
DRUG	GLYC-101 Gel (1.0%)	Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
DRUG	GLYC-101 Placebo	Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-11-18
• Last updated: 2021-10-28
• Results posted: 2011-07-25

Locations

1 site across 1 country: United States