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

Phase 1

Completed

• Conditions: Wounds
• Interventions: Drug: GLYC-101 gel (1.0 %); Drug: Placebo gel

• Registration Number: NCT00656474
• Lead Sponsor: TR Therapeutics

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).

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-04
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-11
• Study Completion: 2008-08
• Results First Submitted: 2011-06-23
• Results First Submitted QC: 2011-06-23
• Results First Posted: 2011-07-25
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GLYC-101 gel (1.0 %)	GLYC-101 Active Retro-auricular Site (1 per participant)
2 Comparator	Placebo gel	Placebo Retro-auricular Site (1 per participant) This arm undergoes laser ablation with subsequent Placebo gel administration

Primary Outcome Measures

Name	Time	Method
Time to Complete Wound Closure (Epithelialization)	Over the course of 1 month following the initial treatment.	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Wound Epithelialized	Day 15 post laser ablation.	The percentage of wound epithelialized was assessed at Day 15 post laser ablation.

Trial Locations

Locations (1)

CLINICAL TESTING CENTER of BEVERLY HILLS; 🇺🇸 Beverly Hills, California, United States