NCT00656474

Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: TR Therapeutics · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.

Detailed description

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).

Conditions

• Wounds

Interventions

Type	Name	Description
DRUG	Placebo gel	Administration of Placebo gel on Day 1, 3 and 5 post ablation.
DRUG	GLYC-101 gel (1.0 %)	Administration on Day 1, 3 and 5 post laser ablation.

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-04-01
• Completion: 2008-08-01
• First posted: 2008-04-11
• Last updated: 2021-10-28
• Results posted: 2011-07-25

Locations

1 site across 1 country: United States