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

• Sponsor: TR Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00656474
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Wounds	Drug: Placebo gel; Drug: GLYC-101 gel (1.0 %)	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 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 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 Start Date: Mar 1, 2008
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

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 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

1. Percentage of Wound Epithelialized [Day 15 post laser ablation.]

   The percentage of wound epithelialized was assessed at Day 15 post laser ablation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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, CLINICAL TESTING CENTER of BEVERLY HILLS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TR Therapeutics
• ClinicalTrials.gov Identifier: NCT00656474
• Other Study ID Numbers: GLYC-101-1a
• First Posted: Apr 11, 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 occurred in March 2008 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 section. Eligible subjects were randomly assigned to receive GLYC-101, 1% or placebo.

Arm/Group Title	GLYC-101 and Placebo
Arm/Group Description	Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site. GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
Period Title: Overall Study
STARTED	12
COMPLETED	11
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	GLYC-101 and Placebo
Arm/Group Description	Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.3 (8.93)
Sex: Female, Male (Count of Participants)
Female	12 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Time to Complete Wound Closure (Epithelialization)
Description	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.
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	GLYC-101 Active Retro-auricular Site (1 Per Participant)	Placebo Retro-auricular Site (1 Per Participant)
Arm/Group Description	GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation	Placebo gel Administration on Day 1, 3 and 5 post laser ablation
Measure Participants	12	12
Median (95% Confidence Interval) [days]	15	15

2. Secondary Outcome

Title	Percentage of Wound Epithelialized
Description	The percentage of wound epithelialized was assessed at Day 15 post laser ablation.
Time Frame	Day 15 post laser ablation.

Outcome Measure Data

Analysis Population Description

Analysis was Per Protocol.

Arm/Group Title	GLYC-101 Active Retro-auricular Site (1 Per Participant)	Placebo Retro-auricular Site (1 Per Participant)
Arm/Group Description	GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation	Placebo gel Administration on Day 1, 3 and 5 post laser ablation
Measure Participants	12	12
Number [percent]	100	100

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 and Placebo
Arm/Group Description	Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site. GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
All Cause Mortality
	GLYC-101 and Placebo
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	GLYC-101 and Placebo
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	GLYC-101 and Placebo
	Affected / at Risk (%)	# Events
Total	12/12 (100%)
Ear and labyrinth disorders
Ear Pruritus	3/12 (25%)	6
General disorders
Granuloma	1/12 (8.3%)	1
Nervous system disorders
Headache	11/12 (91.7%)	21
Skin and subcutaneous tissue disorders
Erythema	12/12 (100%)	24

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.