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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid |
|
| 2 | Experimental | GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid |
|
| 3 | Experimental | GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLYC-101 Gel (0.1%) | Drug | Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over the course of 1 month following the initial treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis/11-point Likert Scale | The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed). | At 1 month following the initial treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Joseph, MD | The 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 Criteria section. Eligible subjects were randomly assigned to receive GLYC-101 0.1%, GLYC-101 1%, or placebo.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| 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 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. | Analysis was Per Protocol. | Posted | Mean | Standard Deviation | 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.
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| 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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HIV test positive | Investigations | MedDRA (11.0) | This Serious Adverse Event is not related to study drugs. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA (11.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Reinhard Koenig, CEO | Glycotex, Inc. | 301-670-2825 | Reinhard.Koenig@glycotexinc.com |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002056 | Burns |
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| GLYC-101 Gel (1.0%) | Drug | Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. |
|
| GLYC-101 Placebo | Drug | Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. |
|
| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| All Treatments Placebo |
|
|
|
| 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). | Posted | Mean | Standard Deviation | scores on a scale | At 1 month following the initial treatment. |
|
|
|
| 0 |
| 9 |
| 9 |
| 9 |
| EG001 | 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. | 0 | 8 | 8 | 8 |
| EG002 | 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. | 1 | 9 | 9 | 9 |
| Impaired healing | General disorders | MedDRA (11.0) |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (11.0) |
|
| Chemical eye injury | Injury, poisoning and procedural complications | MedDRA (11.0) |
|
| Eye pruritus | Eye disorders | MedDRA (11.0) |
|
| Conjunctivitis | Eye disorders | MedDRA (11.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
|
| Headache | Nervous system 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.