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.

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

Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for admission to the study:

• Patients giving informed consent for retro-auricular laser ablation between 25 and 55 years old.
• Retro-auricular area is free of any irritation, scars or dermatologic conditions which might interfere with the study.
• Willing and able to participate in the study and follow all study directions.
• Able to read, understand and sign the consent form.

Exclusion Criteria:

• Pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
• Systemic or cutaneous disease that may interfere with the study results.
• Presence of irritation or dermatologic skin conditions in the retro-auricular area.
• Known allergies to materials within the test formulations.
• Systemic or cutaneous therapy with medication that impacts wound healing (steroids, immune modulators, immune suppressants).