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

Wounds Clinical Trial

Official title:

Double-blind, Randomized, Placebo-controlled Phase 2 Pilot Study to Investigate the Safety and Clinical Outcomes of 1.0 % Topically Applied GLYC-101, Compared to Placebo, in Healthy Subjects Undergoing Retro-auricular Carbon Dioxide Laser Skin Resurfacing.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656474
• Other study ID #: GLYC-101-1a
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2021
• Source: TR Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent over the course of 1 month following the treatment. as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2 Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101 compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Wounds

Intervention

Drug:
• Placebo gel
Administration of Placebo gel on Day 1, 3 and 5 post ablation.
• GLYC-101 gel (1.0 %)
Administration on Day 1, 3 and 5 post laser ablation.

Locations

Country	Name	City	State
United States	CLINICAL TESTING CENTER of BEVERLY HILLS	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
TR Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Complete Wound Closure (Epithelialization)	Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. 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.	Over the course of 1 month following the initial treatment.
Secondary	Percentage of Wound Epithelialized	The percentage of wound epithelialized was assessed at Day 15 post laser ablation.	Day 15 post laser ablation.