Expired Study
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Beverly Hills, California 90210


Purpose:

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


Study summary:

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).


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).


Study is Available At:


Original ID:

GLYC-101-1a


NCT ID:

NCT00656474


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

25 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Glycotex, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:John Joseph, MD
Principal Investigator
CLINICAL TESTING CENTER of BEVERLY HILLS

Study Dates

Start Date:March 2008
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:June 2011
Last Changed Date:June 9, 2011
First Received Date:April 7, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Cosmesis
Time Frame:At 1 month following the initial treatment.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Time to complete wound closure (epithelialization)
Time Frame:Over the course of 1 month following the initial treatment.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:GLYC-101 Placebo
Description:Administration of placebo on day 1, 3 and 5 post ablation.
Arm Name:2 Comparator
Intervention Type:Drug
Name:GLYC-101 gel (1.0 %)
Description:Administration on day 1, 3 and 5 post laser ablation.
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:GLYC-101 active
Study Arm Type:Placebo Comparator
Arm Name:2 Comparator
Description:GLYC-101 Placebo This arm undergoes laser ablation with subsequent GLYC-101 Placebo gel administration

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Glycotex, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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