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

Phase 2
Completed
Conditions
Wounds
Interventions
Drug: GLYC-101 Gel (0.1%)
Drug: GLYC-101 Gel (1.0%)
Drug: GLYC-101 Placebo
Registration Number
NCT00792688
Lead Sponsor
TR Therapeutics
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1GLYC-101 Gel (0.1%)GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid
1GLYC-101 PlaceboGLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid
2GLYC-101 Gel (1.0%)GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid
2GLYC-101 PlaceboGLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid
3GLYC-101 Gel (1.0%)GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid
3GLYC-101 Gel (0.1%)GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid
Primary Outcome Measures
NameTimeMethod
Time to Complete Wound Closure (Epithelialization)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 Outcome Measures
NameTimeMethod
Cosmesis/11-point Likert ScaleAt 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).

Trial Locations

Locations (1)

CLINICAL TESTING CENTER of BEVERLY HILLS

🇺🇸

Beverly Hills, California, United States

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

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