Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation

Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.

Official Title
-----------------
Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Investigate the Safety and Efficacy of 0.1% and 1.0% Topically Applied GLYC-101, Compared to Placebo, in Patients Undergoing Carbon Dioxide Laser Skin Resurfacing of the Lower Eyelids.

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Drug: GLYC-101 Gel (0.1%)
* Drug: GLYC-101 Gel (1.0%)
* Drug: GLYC-101 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female healthy volunteer subjects, between 25 and 70 years of age, giving informed consent for facial laser ablation of the lower eyelid areas for the purpose of wrinkle removal. Lower eyelid skin is free of any irritation, scarring 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 prior to any study related procedures. Exclusion Criteria: Female subjects who are pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test. Presence of irritation or dermatologic skin conditions in the lower eyelid area. Known allergies to materials within the test formulations (i.e., yeast and/or yeast products). Use of topical or systemic drugs (corticosteroids, retinoids, immune modulators, immune suppressants, drugs with potential for contact dermatitis, drugs with potential for skin discoloration) that may have an effect on wound healing or may impact skin pigmentation. A history, upon wounding, of developing thickened scars, keloids, or excessive pigment change. An unstable or severe inter-current medical condition that, in the opinion of the investigator, might interfere with interpretation of study results or render the subject at high risk for treatment complications. Use of any investigational medication or device for any indication within 30 days of screening.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid | Drug: GLYC-101 Gel (0.1%)<br>* Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.<br>Drug: GLYC-101 Placebo<br>* Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.<br>|
| Experimental: 2<br>GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid | Drug: GLYC-101 Gel (1.0%)<br>* Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.<br>Drug: GLYC-101 Placebo<br>* Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.<br>|
| Experimental: 3<br>GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid | Drug: GLYC-101 Gel (0.1%)<br>* Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.<br>Drug: GLYC-101 Gel (1.0%)<br>* Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete Wound Closure (Epithelialization) | Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. 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 |
| --- | --- | --- |
| Cosmesis/11-point Likert Scale | The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed). | At 1 month following the initial treatment. | 

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