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Completed

NCT Number: NCT00792688

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

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.

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Key information

Conditions

Wounds Burns Wounds and Injuries

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CLINICAL TESTING CENTER of BEVERLY HILLS

Beverly Hills, California, 90210, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

GLYC-101 Gel (0.1%)

Drug

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

GLYC-101 Gel (1.0%)

Drug

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

GLYC-101 Placebo

Drug

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

Primary outcomes

  1. Time to Complete Wound Closure (Epithelialization)

    Time frame: Over the course of 1 month following the initial treatment.

    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.

Secondary outcomes

  1. Cosmesis/11-point Likert Scale

    Time frame: At 1 month following the initial treatment.

    The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).

Sponsors and collaborators

Lead sponsor

TR Therapeutics

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 18, 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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