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

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ClinicalTrials.gov Identifier: NCT00656474
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : July 25, 2011
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
Glycotex, Inc.

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

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

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : March 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Time to Complete Wound Closure (Epithelialization) [ Time Frame: Over the course of 1 month following the initial treatment. ]
    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 :
  1. Percentage of Wound Epithelialized [ Time Frame: Day 15 post laser ablation. ]
    The percentage of wound epithelialized was assessed at Day 15 post laser ablation.



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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 11, 2008    Key Record Dates
Results First Posted: July 25, 2011
Last Update Posted: July 26, 2011
Last Verified: July 2011

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