Wounds
Conditions
Keywords
burn wounds, wound healing
Brief summary
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.
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).
Interventions
DRUGPlacebo gel
Administration of Placebo gel on Day 1, 3 and 5 post ablation.
DRUGGLYC-101 gel (1.0 %)
Administration on Day 1, 3 and 5 post laser ablation.
Sponsors
TR Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Wound Epithelialized | Day 15 post laser ablation. | The percentage of wound epithelialized was assessed at Day 15 post laser ablation. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| GLYC-101 and Placebo Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other Reason | 1 |
Baseline characteristics
| Characteristic | GLYC-101 and Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 50.3 years STANDARD_DEVIATION 8.93 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: Over the course of 1 month following the initial treatment.
Population: Analysis was Per Protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GLYC-101 Active Retro-auricular Site (1 Per Participant) | Time to Complete Wound Closure (Epithelialization) | 15 days |
| Placebo Retro-auricular Site (1 Per Participant) | Time to Complete Wound Closure (Epithelialization) | 15 days |
Secondary
Percentage of Wound Epithelialized
The percentage of wound epithelialized was assessed at Day 15 post laser ablation.
Time frame: Day 15 post laser ablation.
Population: Analysis was Per Protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLYC-101 Active Retro-auricular Site (1 Per Participant) | Percentage of Wound Epithelialized | 100 percent |
| Placebo Retro-auricular Site (1 Per Participant) | Percentage of Wound Epithelialized | 100 percent |