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).
Subjects meeting all of the following criteria will be considered for admission to the
- Patients giving informed consent for retro-auricular laser ablation between 25 and 55
- 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.
- 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).