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

NCT ID: NCT00656474

Last Updated: 2021-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Wounds

Keywords

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burn wounds wound healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

GLYC-101 gel (1.0 %)

Intervention Type DRUG

Administration on Day 1, 3 and 5 post laser ablation.

2 Comparator

Placebo Retro-auricular Site (1 per participant)

This arm undergoes laser ablation with subsequent Placebo gel administration

Group Type PLACEBO_COMPARATOR

Placebo gel

Intervention Type DRUG

Administration of Placebo gel on Day 1, 3 and 5 post ablation.

Interventions

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Placebo gel

Administration of Placebo gel on Day 1, 3 and 5 post ablation.

Intervention Type DRUG

GLYC-101 gel (1.0 %)

Administration on Day 1, 3 and 5 post laser ablation.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TR Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Joseph, MD

Role: PRINCIPAL_INVESTIGATOR

CLINICAL TESTING CENTER of BEVERLY HILLS

Locations

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CLINICAL TESTING CENTER of BEVERLY HILLS

Beverly Hills, California, United States

Site Status

Countries

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United States

Other Identifiers

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GLYC-101-1a

Identifier Type: -

Identifier Source: org_study_id