Phase 2 Completed N=12 Randomized Quadruple-blind Treatment

Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation

Wounds

Source: ClinicalTrials.gov NCT00656474 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2011

Primary outcomePrimary: Time to Complete Wound Closure (Epithelialization) — 15; 15 days

Summary

Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Complete Wound Closure (Epithelialization)	15; 15	—
SECONDARY Percentage of Wound Epithelialized	100; 100	—

Eligibility Criteria

Inclusion Criteria

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 Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00656474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.