Wounds
Conditions
Keywords
burn wounds, wound healing
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.
Interventions
DRUGGLYC-101 Gel (0.1%)
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
DRUGGLYC-101 Gel (1.0%)
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
DRUGGLYC-101 Placebo
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
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 70 Years
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.
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 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid 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. | 9 |
| GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid 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. | 8 |
| GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other 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. | 9 |
| Total | 26 |
Baseline characteristics
| Characteristic | 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 | GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 9 Participants | 24 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 12.83 | 53.3 years STANDARD_DEVIATION 9.41 | 53.1 years STANDARD_DEVIATION 7.98 | 51.1 years STANDARD_DEVIATION 10.25 |
| Region of Enrollment United States | 8 participants | 9 participants | 9 participants | 26 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 8 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 9 | 8 / 8 | 9 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 | 1 / 9 |
Outcome results
Primary
Time to Complete Wound Closure (Epithelialization)
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.
Population: Analysis was Per Protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Treatments GLYC-101 Gel, 0.1% | Time to Complete Wound Closure (Epithelialization) | 10.9 days | Standard Deviation 5.17 |
| All Treatments GLYC-101 Gel, 1.0% | Time to Complete Wound Closure (Epithelialization) | 13.1 days | Standard Deviation 8.31 |
| All Treatments Placebo | Time to Complete Wound Closure (Epithelialization) | 16.3 days | Standard Deviation 9.93 |
p-value: 0.0062Wilcoxon (Mann-Whitney)
p-value: 0.0331Wilcoxon (Mann-Whitney)
Secondary
Cosmesis/11-point Likert Scale
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Treatments GLYC-101 Gel, 0.1% | Cosmesis/11-point Likert Scale | 8.9 scores on a scale | Standard Deviation 1.28 |
| All Treatments GLYC-101 Gel, 1.0% | Cosmesis/11-point Likert Scale | 8.6 scores on a scale | Standard Deviation 1.17 |
| All Treatments Placebo | Cosmesis/11-point Likert Scale | 8.5 scores on a scale | Standard Deviation 1.5 |