Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | GLYC-101 Active Retro-auricular Site (1 per participant) |
|
| 2 Comparator | Placebo Comparator | Placebo Retro-auricular Site (1 per participant) This arm undergoes laser ablation with subsequent Placebo gel administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo gel | Drug | Administration of Placebo gel on Day 1, 3 and 5 post ablation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Wound Epithelialized | The percentage of wound epithelialized was assessed at Day 15 post laser ablation. | Day 15 post laser ablation. |
Not provided
Inclusion Criteria:
Subjects meeting all of the following criteria will be considered for admission to the study:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Joseph, MD | CLINICAL TESTING CENTER of BEVERLY HILLS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLINICAL TESTING CENTER of BEVERLY HILLS | Beverly Hills | California | 90210 | United States |
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.
Recruitment occurred in March 2008 at a single site, Clinical Testing Center of Beverly Hills, Beverly Hills, California, United States, 90210.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was Per Protocol. | Posted | Median | 95% Confidence Interval | days | Over the course of 1 month following the initial treatment. |
|
Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Pruritus | Ear and labyrinth disorders | MedDRA (11.0) |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Reinhard Koenig, CEO | Glycotex | 301-670-2825 | Reinhard.Koenig@glycotexinc.com |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002056 | Burns |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GLYC-101 gel (1.0 %) |
| Drug |
Administration on Day 1, 3 and 5 post laser ablation. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo gel Administration on Day 1, 3 and 5 post laser ablation |
|
|
| Secondary | Percentage of Wound Epithelialized | The percentage of wound epithelialized was assessed at Day 15 post laser ablation. | Analysis was Per Protocol. | Posted | Number | percent | Day 15 post laser ablation. |
|
|
|
| 0 |
| 12 |
| 12 |
| 12 |
| Granuloma | General disorders | MedDRA (11.0) |
|
| Headache | Nervous system disorders | MedDRA (11.0) |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
|
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.