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

NCT ID: NCT00792688

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-01-31

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 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.

Conditions

Wounds

Keywords

burn wounds; wound healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid

Group Type: EXPERIMENTAL

GLYC-101 Gel (0.1%)

Intervention Type: DRUG

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

GLYC-101 Placebo

Intervention Type: DRUG

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

2

GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid

Group Type: EXPERIMENTAL

GLYC-101 Gel (1.0%)

Intervention Type: DRUG

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

GLYC-101 Placebo

Intervention Type: DRUG

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

3

GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid

Group Type: EXPERIMENTAL

GLYC-101 Gel (0.1%)

Intervention Type: DRUG

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

GLYC-101 Gel (1.0%)

Intervention Type: DRUG

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

Interventions

GLYC-101 Gel (0.1%)

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

Intervention Type: DRUG

GLYC-101 Gel (1.0%)

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

Intervention Type: DRUG

GLYC-101 Placebo

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TR Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Joseph, MD

Role: PRINCIPAL_INVESTIGATOR

The Clinical Testing Center of Beverly Hills

Locations

CLINICAL TESTING CENTER of BEVERLY HILLS

Beverly Hills, California, United States

Countries

United States

Other Identifiers

GLYC-101-1b

Identifier Type: -

Identifier Source: org_study_id