Safety and Efficacy of Topical TolaSure on Skin Punch Biopsies in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase One, Single Center, Open-Label, University of Miami Medical Center, 14 Day Study Evaluating the Safety, Cutaneous Tolerability, and Efficacy of TolaSure Topical Gel in Healthy Volunteers

Conditions
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Wound Healing

Intervention / Treatment
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* Drug: TolaSure Topical Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Males and Females > 18 years of age Health history review Physical exam Blood and urine clinical chemistries Pregnancy test Drug screen Exclusion Criteria: Acute or chronic skin disorders (e.g. acne, psoriasis, dermatitis) Prone to keloids or hypertrophic scarring Topical or systemic antibiotics within 4 weeks of study enrollment Subjects with mental illnesses Diagnosed with Diabetes Type I/II Surgery within the previous 3 months (except for minor cosmetic or dental procedures) History of severe vitamin or mineral deficiency History of drug or alcohol abuse (as defined by the Investigator) Smoking/Vaping HIV/AIDS Consistently taking steroids and/or non-steroidal anti-inflammatory drugs Cancer diagnosis in the last year Currently receiving chemotherapy or radiation Women who are pregnant, nursing or planning a pregnancy Hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study Treatment with any investigational agent within one month before treatment application for this trial Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 Percent TolaSure Topical Gel<br> | Drug: TolaSure Topical Gel<br>* TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.<br>|
| Active Comparator: 1.5 Percent TolaSure Topical Gel<br> | Drug: TolaSure Topical Gel<br>* TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.<br>|
| Active Comparator: 0.5 Percent TolaSure Topical Gel<br> | Drug: TolaSure Topical Gel<br>* TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.<br>|
| Placebo Comparator: Topical Vehicle Gel<br> | Drug: TolaSure Topical Gel<br>* TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Participants, Skin, Dermal, Biopsy