Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation

Wounds Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792688
• Other study ID #: GLYC-101-1b
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: January 2010

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wounds

Intervention

Drug:
• GLYC-101 Gel (0.1%)
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
• GLYC-101 Gel (1.0%)
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
• GLYC-101 Placebo
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

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 daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. 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	Cosmesis/11-point Likert Scale	The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).	At 1 month following the initial treatment.