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

NCT00656474 | Completed Phase 1 Results

• 1 other identifier: GLYC-101-1a
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wounds

Keywords

burn wounds; wound healing

Outcome Measures

Primary Outcomes (1)

• Time to Complete Wound Closure (Epithelialization)

  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 Outcomes (1)

• Percentage of Wound Epithelialized

  Day 15 post laser ablation.

Study Arms (2)

1

EXPERIMENTAL

GLYC-101 Active Retro-auricular Site (1 per participant)

Drug: GLYC-101 gel (1.0 %)

2 Comparator

PLACEBO COMPARATOR

Placebo Retro-auricular Site (1 per participant) This arm undergoes laser ablation with subsequent Placebo gel administration

Drug: Placebo gel

Interventions

Placebo gel DRUG

Administration of Placebo gel on Day 1, 3 and 5 post ablation.

2 Comparator

GLYC-101 gel (1.0 %) DRUG

Administration on Day 1, 3 and 5 post laser ablation.

1

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• TR Therapeutics: lead

Study Sites (1)

CLINICAL TESTING CENTER of BEVERLY HILLS

Beverly Hills, California, 90210, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Burns

Results Point of Contact

• Title: Dr. Reinhard Koenig, CEO
• Organization: Glycotex

Reinhard.Koenig@glycotexinc.com

301-670-2825

Study Officials

• John Joseph, MD

  CLINICAL TESTING CENTER of BEVERLY HILLS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 28, 2021
• Results First Posted: July 25, 2011

Record last verified: 2021-10

Locations

US (1)