- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00656474
Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation
October 26, 2021 updated by: TR Therapeutics
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 is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
12
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90210
- Clinical Testing Center of Beverly Hills
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
GLYC-101 Active Retro-auricular Site (1 per participant)
|
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 |
Administration of Placebo gel on Day 1, 3 and 5 post ablation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Over the course of 1 month following the initial treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Wound Epithelialized
Time Frame: Day 15 post laser ablation.
|
The percentage of wound epithelialized was assessed at Day 15 post laser ablation.
|
Day 15 post laser ablation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Joseph, MD, Clinical Testing Center of Beverly Hills
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
April 7, 2008
First Submitted That Met QC Criteria
April 10, 2008
First Posted (Estimate)
April 11, 2008
Study Record Updates
Last Update Posted (Actual)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 26, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GLYC-101-1a
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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