Clinical trial NCT00792688: Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wounds
Keywords: burn wounds
wound healing
Lead sponsor: TR Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time to Complete Wound Closure (Epithelialization)
timeFrame: Over the course of 1 month following the initial treatment.
Secondary outcomes:
measure: Cosmesis/11-point Likert Scale
timeFrame: At 1 month following the initial treatment.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: CLINICAL TESTING CENTER of BEVERLY HILLS
state: California
Study officials:
affiliation: The Clinical Testing Center of Beverly Hills
name: John Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References: