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

This study has been completed.
Sponsor:
Information provided by:
Glycotex, Inc.
ClinicalTrials.gov Identifier:
NCT00656474
First received: April 7, 2008
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Wounds
Drug: Placebo gel
Drug: GLYC-101 gel (1.0 %)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled Phase 2 Pilot Study to Investigate the Safety and Clinical Outcomes of 1.0 % Topically Applied GLYC-101, Compared to Placebo, in Healthy Subjects Undergoing Retro-auricular Carbon Dioxide Laser Skin Resurfacing.

Further study details as provided by Glycotex, Inc.:

Primary Outcome Measures:
  • Time to Complete Wound Closure (Epithelialization) [ Time Frame: Over the course of 1 month following the initial treatment. ] [ Designated as safety issue: No ]
    Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. 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.


Secondary Outcome Measures:
  • Percentage of Wound Epithelialized [ Time Frame: Day 15 post laser ablation. ] [ Designated as safety issue: No ]
    The percentage of wound epithelialized was assessed at Day 15 post laser ablation.


Enrollment: 12
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
GLYC-101 Active Retro-auricular Site (1 per participant)
Drug: GLYC-101 gel (1.0 %)
Administration on Day 1, 3 and 5 post laser ablation.
Placebo Comparator: 2 Comparator

Placebo Retro-auricular Site (1 per participant)

This arm undergoes laser ablation with subsequent Placebo gel administration

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

Detailed 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).

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656474

Locations
United States, California
CLINICAL TESTING CENTER of BEVERLY HILLS
Beverly Hills, California, United States, 90210
Sponsors and Collaborators
Glycotex, Inc.
Investigators
Principal Investigator: John Joseph, MD CLINICAL TESTING CENTER of BEVERLY HILLS
  More Information

No publications provided

Responsible Party: John H. Joseph, MD, 9400 Brighton Way, Suite 203, Beverly Hills, CA 90210, The Clinical Testing Center of Beverly Hills
ClinicalTrials.gov Identifier: NCT00656474     History of Changes
Other Study ID Numbers: GLYC-101-1a
Study First Received: April 7, 2008
Results First Received: June 23, 2011
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Glycotex, Inc.:
burn wounds
wound healing

ClinicalTrials.gov processed this record on April 17, 2014