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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014