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

• Sponsor: TR Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00792688
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 3
• Duration (Months): 15
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Wounds	Drug: GLYC-101 Gel (0.1%); Drug: GLYC-101 Gel (1.0%); Drug: GLYC-101 Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 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 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.
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel 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.
Experimental: 2 GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel 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.
Experimental: 3 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.

Outcome Measures

Primary Outcome Measures

1. Time to Complete Wound Closure (Epithelialization) [Over the course of 1 month following the initial treatment.]

   Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. 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. Cosmesis/11-point Likert Scale [At 1 month following the initial treatment.]

   The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	CLINICAL TESTING CENTER of BEVERLY HILLS	Beverly Hills	California	United States	90210

Sponsors and Collaborators

• TR Therapeutics

Investigators

• Principal Investigator: John Joseph, MD, The Clinical Testing Center of Beverly Hills

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TR Therapeutics
• ClinicalTrials.gov Identifier: NCT00792688
• Other Study ID Numbers: GLYC-101-1b
• First Posted: Nov 18, 2008
• Last Update Posted: Oct 28, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by TR Therapeutics: burn wounds; wound healing

Study Results

Participant Flow

Recruitment Details	Recruitment started in October 2008 and ended in 2009 at a single site, Clinical Testing Center of Beverly Hills, Beverly Hills, California, United States, 90210.
Pre-assignment Detail	All subjects needed to meet specific inclusion and exclusion criteria as described in the Eligibility Criteria section. Eligible subjects were randomly assigned to receive GLYC-101 0.1%, GLYC-101 1%, or placebo.

Arm/Group Title	GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid	GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid	GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
Arm/Group Description	GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5. Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.	GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5. Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.	GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5. GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Period Title: Overall Study
STARTED	9	8	9
COMPLETED	9	8	9
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid	GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid	GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other	Total
Arm/Group Description	GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5. Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.	GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5. Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.	GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5. GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.	Total of all reporting groups
Overall Participants	9	8	9	26
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	9 100%	7 87.5%	8 88.9%	24 92.3%
>=65 years	0 0%	1 12.5%	1 11.1%	2 7.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.1 (7.98)	46.4 (12.83)	53.3 (9.41)	51.1 (10.25)
Sex: Female, Male (Count of Participants)
Female	8 88.9%	8 100%	6 66.7%	22 84.6%
Male	1 11.1%	0 0%	3 33.3%	4 15.4%
Region of Enrollment (participants) [Number]
United States	9 100%	8 100%	9 100%	26 100%

Outcome Measures

1. Primary Outcome

Title	Time to Complete Wound Closure (Epithelialization)
Description	Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. 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.
Time Frame	Over the course of 1 month following the initial treatment.

Outcome Measure Data

Analysis Population Description

Analysis was Per Protocol.

Arm/Group Title	All Treatments GLYC-101 Gel, 0.1%	All Treatments GLYC-101 Gel, 1.0%	All Treatments Placebo
Arm/Group Description
Measure Participants	18	17	17
Mean (Standard Deviation) [days]	10.9 (5.17)	13.1 (8.31)	16.3 (9.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Treatments GLYC-101 Gel, 0.1%, All Treatments Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0062
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	All Treatments GLYC-101 Gel, 1.0%, All Treatments Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0331
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Cosmesis/11-point Likert Scale
Description	The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).
Time Frame	At 1 month following the initial treatment.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Treatments GLYC-101 Gel, 0.1%	All Treatments GLYC-101 Gel, 1.0%	All Treatments Placebo
Arm/Group Description
Measure Participants	18	17	17
Mean (Standard Deviation) [scores on a scale]	8.9 (1.28)	8.6 (1.17)	8.5 (1.50)

Adverse Events

Time Frame	Adverse Events (AEs) were collected over the course of 1 month.
Adverse Event Reporting Description	AEs were collected at baseline and each study visit.
Arm/Group Title	GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid		GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid		GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
Arm/Group Description	GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5. Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.		GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5. Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.		GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5. GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
All Cause Mortality
	GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid		GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid		GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid		GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid		GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/8 (0%)		1/9 (11.1%)
Investigations
HIV test positive	0/9 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1
Other (Not Including Serious) Adverse Events
	GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid		GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid		GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100%)		8/8 (100%)		9/9 (100%)
Eye disorders
Eye pruritus	4/9 (44.4%)	11	3/8 (37.5%)	7	6/9 (66.7%)	10
Conjunctivitis	0/9 (0%)	0	1/8 (12.5%)	2	0/9 (0%)	0
Gastrointestinal disorders
Nausea	1/9 (11.1%)	1	1/8 (12.5%)	1	0/9 (0%)	0
Vomiting	1/9 (11.1%)	1	0/8 (0%)	0	0/9 (0%)	0
General disorders
Application site pain	9/9 (100%)	70	8/8 (100%)	62	9/9 (100%)	71
Impaired healing	2/9 (22.2%)	4	1/8 (12.5%)	1	1/9 (11.1%)	2
Injury, poisoning and procedural complications
Procedural pain	6/9 (66.7%)	11	5/8 (62.5%)	14	6/9 (66.7%)	13
Chemical eye injury	0/9 (0%)	0	1/8 (12.5%)	1	0/9 (0%)	0
Musculoskeletal and connective tissue disorders
Pain in extremity	0/9 (0%)	0	1/8 (12.5%)	1	0/9 (0%)	0
Nervous system disorders
Headache	0/9 (0%)	0	0/8 (0%)	0	1/9 (11.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of up to 90 days. The sponsor can require changes to the communication to remove any confidential information.