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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
University of Miami
Miami, Florida, United States
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.
Time frame: 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)
Time frame: Day 1, 2, 7 and 14.
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.
Time frame: Day 1, 2, 7 and 14.
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