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

TR Therapeutics

Status and phase: Completed; Phase 2

Conditions: Wounds

Treatments: Drug: GLYC-101 Gel (0.1%); Drug: GLYC-101 Gel (1.0%); Drug: GLYC-101 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00792688

GLYC-101-1b

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: GLYC-101 Placebo

Drug: GLYC-101 Gel (0.1%)

2

Experimental group

Description:

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

Treatment:

Drug: GLYC-101 Placebo

Drug: GLYC-101 Gel (1.0%)

3

Experimental group

Description:

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

Treatment:

Drug: GLYC-101 Gel (0.1%)

Drug: GLYC-101 Gel (1.0%)