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Completed

NCT Number: NCT00656474

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

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

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Key information

Conditions

Wounds Burns Wounds and Injuries

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CLINICAL TESTING CENTER of BEVERLY HILLS

Beverly Hills, California, 90210, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo Gel

Drug

Administration of Placebo gel on Day 1, 3 and 5 post ablation.

GLYC-101 gel (1.0 %)

Drug

Administration on Day 1, 3 and 5 post laser ablation.

Primary outcomes

  1. Time to Complete Wound Closure (Epithelialization)

    Time frame: 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 outcomes

  1. Percentage of Wound Epithelialized

    Time frame: Day 15 post laser ablation.

    The percentage of wound epithelialized was assessed at Day 15 post laser ablation.

Sponsors and collaborators

Lead sponsor

TR Therapeutics

Industry

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 11, 2008
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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