Conditions: Wounds
Keywords: burn wounds wound healing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: yes

Brief 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).

Arms:
arm 1: GLYC-101 Active Retro-auricular Site (1 per participant) arm 2: Placebo Retro-auricular Site (1 per participant)

This arm undergoes laser ablation with subsequent Placebo gel administration

Interventions: intervention 1: Placebo gel intervention 2: GLYC-101 gel (1.0 %)
Intervention descriptions: intervention 1: Administration of Placebo gel on Day 1, 3 and 5 post ablation. intervention 2: Administration on Day 1, 3 and 5 post laser ablation.

Protocol document: