Status:
COMPLETED
Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation
Lead Sponsor:
TR Therapeutics
Conditions:
Wounds
Eligibility:
All Genders
25-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.
Detailed Description
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 ret...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00656474
Start Date
March 1 2008
End Date
August 1 2008
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