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| Name | Class |
|---|---|
| Symbio, LLC | INDUSTRY |
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TolaSure is a topical gel for the promotion of accelerated wound healing. This phase II study will primarily assess the efficacy of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. Safety, cutaneous tolerability, wound pain control, and quality of healing will also be assessed. A total of 80 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will be monitored for safety and efficacy until wound closure (estimation about 8 weeks) following topical administration of TolaSure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 Percent TolaSure Topical Gel | Active Comparator | 5%(w/w) TolaSure Gel |
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| Topical Vehicle Gel | Placebo Comparator | Vehicle Gel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TolaSure Topical Gel | Drug | TolaSure topical gel is applied to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Accelerated Wound Closure | Time-to-closure will be calculated by the number of days from biopsy to wound closure. Wound closure (changes in wound area (mm^2) over time) will be determined by the digital imaging platform software with Principal Investigator confirmation. | Day 1, 2, and 7, then weekly until closure (estimated 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Area Reduction after Four Weeks | Wound area measurements (mm^2) will be calculated at week 4 by using a digital imaging. A percent reduction in area at week 4 will be calculated by comparing the initial area of the biopsy at Day 1 to the week 4 biopsy area. | Week 4 |
| Wound Pain Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| J&S Studies |
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| Topical Vehicle Gel | Drug | TolaSure Vehicle Gel is applied topically to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure. |
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Wound-related pain or discomfort will be assessed, using the Visual Analog Scale (VAS) for Pain, for each individual wound site as pain at rest followed by pain to touch. The VAS Pain is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. Pain will be defined per the following scale: None - 0-4 mm; Mild - 5-44 mm: Moderate - 45-74; Severe - 75-100 mm |
| Day 2 and 7, then weekly until wound closure (estimated 8 weeks) |
| Quality of Healing | Patient and Observer Scar Assessment Scale (POSAS) version 2.0 will be used to assess the quality of healing of each biopsy site at the end of the study once both wounds are closed. | End of study (estimated 8 weeks) |
| Cutaneous Tolerability | Cutaneous tolerability will include an evaluation of erythema and edema following the modified Draize scoring system. Draize scores will be recorded and changes from baseline Draize scores will be monitored over the course of the time frame. Draize Scoring System. Erythema: 0-No Erythema, 1-Slight Erythema, 2-Well Defined Erythema, 3- Moderate or Severe Erythema, 4- Severe Erythema or slight eschar formation. Edema: 0- No Edema, 1- Very Slight Edema(barely perceptible), 2-Slight Edema (well defined edges), 3-Moderate Edema (raised >1mm), 4- Severe Edema (raised >1mm and extending beyond the area of exposure) | Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks) |
| Blood and Urine Chemistries | Absolute values and changes over time of clinical chemistries including; Absolute values and changes over time of clinical blood and urine chemistries including; Hematology and Coagulation, Coagulation, Serum Chemistry, and Urinalysis. Blood and urine analytes are measured on a per mL basis. | Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks) |
| College Station |
| Texas |
| 77845 |
| United States |