Status:
COMPLETED
Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
Lead Sponsor:
TR Therapeutics
Conditions:
Wounds
Eligibility:
All Genders
25-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00792688
Start Date
October 1 2008
End Date
January 1 2010
Last Update
October 28 2021
Active Locations (1)
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1
CLINICAL TESTING CENTER of BEVERLY HILLS
Beverly Hills, California, United States, 90210