Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation - Full Text View

Sponsored by:	Glycotex, Inc.
Information provided by:	Glycotex, Inc.
ClinicalTrials.gov Identifier:	NCT00792688

Purpose

The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.

Condition	Intervention	Phase
Wounds	Drug: GLYC-101 Gel (0.1%) Drug: GLYC-101 Gel (1.0%) Drug: GLYC-101 Placebo	Phase II

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Investigate the Safety and Efficacy of 0.1% and 1.0% Topically Applied GLYC-101, Compared to Placebo, in Patients Undergoing Carbon Dioxide Laser Skin Resurfacing of the Lower Eyelids.

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 ]

Secondary Outcome Measures:

Cosmesis [ Time Frame: At 1 month following the initial treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	October 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Placebo on the other eyelid	Drug: GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. Drug: GLYC-101 Placebo Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
2: Experimental GLYC-101 Gel, 1.0% on one eyelid and GLYC-101 Placebo on the other eyelid	Drug: GLYC-101 Gel (1.0%) Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. Drug: GLYC-101 Placebo Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
3: Experimental GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid	Drug: GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. Drug: GLYC-101 Gel (1.0%) Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male and female healthy volunteer subjects, between 25 and 70 years of age, giving informed consent for facial laser ablation of the lower eyelid areas for the purpose of wrinkle removal.
Lower eyelid skin is free of any irritation, scarring 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 prior to any study related procedures.

Exclusion Criteria:

Female subjects who are pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
Presence of irritation or dermatologic skin conditions in the lower eyelid area.
Known allergies to materials within the test formulations (i.e., yeast and/or yeast products).
Use of topical or systemic drugs (corticosteroids, retinoids, immune modulators, immune suppressants, drugs with potential for contact dermatitis, drugs with potential for skin discoloration) that may have an effect on wound healing or may impact skin pigmentation.
A history, upon wounding, of developing thickened scars, keloids, or excessive pigment change.
An unstable or severe inter-current medical condition that, in the opinion of the investigator, might interfere with interpretation of study results or render the subject at high risk for treatment complications.
Use of any investigational medication or device for any indication within 30 days of screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792688

Contacts

Contact: Reinhard Koenig, Dr.	301-670-2825	reinhard.koenig@glycotexinc.com
Contact: John Joseph, MD	310-859-7193	drjohnjoseph@sbcglobal.net

Locations

United States, California
CLINICAL TESTING CENTER of BEVERLY HILLS	Recruiting
Beverly Hills, California, United States, 90210
Contact: John Joseph, MD 310-859-7193
Principal Investigator: John Joseph, MD

Sponsors and Collaborators

Glycotex, Inc.

Investigators

Principal Investigator:

John Joseph, MD

The Clinical Testing Center of Beverly Hills

More Information

Responsible Party:	The Clinical Testing Center of Beverly Hills ( John H. Joseph, MD/ Principal Investigator )
Study ID Numbers:	GLYC-101-1b
Study First Received:	November 14, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00792688
Health Authority:	United States: Food and Drug Administration

Keywords provided by Glycotex, Inc.:

burn wounds
wound healing

Study placed in the following topic categories:

Burns

ClinicalTrials.gov processed this record on January 15, 2009