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

TR Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Wounds

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00656474

GLYC-101-1a

Details and patient eligibility

About

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

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

GLYC-101 Active Retro-auricular Site (1 per participant)

Treatment:

Drug: GLYC-101 gel (1.0 %)

2 Comparator

Placebo Comparator group

Description:

Placebo Retro-auricular Site (1 per participant) This arm undergoes laser ablation with subsequent Placebo gel administration

Treatment:

Drug: Placebo gel