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| Name | Class |
|---|---|
| University of Miami | OTHER |
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TolaSure is a topical gel for the promotion of wound healing. This phase I study will assess the safety, tolerability and clinical effect of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. A total of 26 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will monitored for safety and efficacy over the course of 2 weeks following daily topical administration of TolaSure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 Percent TolaSure Topical Gel | Active Comparator |
| |
| 1.5 Percent TolaSure Topical Gel | Active Comparator |
| |
| 0.5 Percent TolaSure Topical Gel | Active Comparator |
| |
| Topical Vehicle Gel | Placebo Comparator |
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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 over the course of 2 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1, 2, 7 and 14. |
| 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, 7 and 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Closure | Imaging of punch biopsies to monitor for healing and wound closure including measurement of changes in wound area (mm^2) over time will be assessed using digital imaging and analyzed using wound tracing techniques followed by the use of appropriate statistics. | Day 1, 2, 7 and 14. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen McGuire, PhD | BioMendics, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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Each patient receives each of the 4 treatment arms. It is closest to a single-subject design where each participant serves as their own control. The placement of treatments on each of the 4 wounds is randomized and assessed by a blinded outcomes assessor.
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Outcomes Assessor is blinded to treatment groups and vehicle control.