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

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

Detailed Description
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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).

Official Title
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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.

Conditions
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Wounds

Intervention / Treatment
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* Drug: Placebo gel
* Drug: GLYC-101 gel (1.0 %)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>GLYC-101 Active Retro-auricular Site (1 per participant) | Drug: GLYC-101 gel (1.0 %)<br>* Administration on Day 1, 3 and 5 post laser ablation.<br>|
| Placebo Comparator: 2 Comparator<br>Placebo Retro-auricular Site (1 per participant) This arm undergoes laser ablation with subsequent Placebo gel administration | Drug: Placebo gel<br>* Administration of Placebo gel on Day 1, 3 and 5 post ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete Wound Closure (Epithelialization) | Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed. | Over the course of 1 month following the initial treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Wound Epithelialized | The percentage of wound epithelialized was assessed at Day 15 post laser ablation. | Day 15 post laser ablation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burn wounds, wound healing