Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Closed Label, Randomized, Double Blind Study for the Treatment of Acute Induced Wounds With TolaSure Gel, 5% w/w in Healthy Volunteers

Conditions
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Wound Healing

Intervention / Treatment
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* Drug: TolaSure Topical Gel
* Drug: Topical Vehicle 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 Negative pregnancy test Exclusion Criteria: Acute or chronic skin disorders (e.g. psoriasis); Acne or dermatitis at the test site; Prone to keloids or hypertrophic scarring; Topical or systemic antibiotics within 4 weeks of study enrollment; Subjects with known severe mental illness which, in the investigator's opinion, may prevent informed consent or interfere with the subject's ability to comply with study protocol procedures; Diagnosed with Diabetes Type I/II or glucose results indicative of prediabetic condition; Morbidly obese with a Body Mass Index (BMI) ≥ 40; 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. Subjects may use NSAIDs on an as needed basis with no more than 7 days of consecutive use; Cancer diagnosis in the last 5 years; 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 Percent TolaSure Topical Gel<br>5%(w/w) TolaSure Gel | Drug: TolaSure Topical Gel<br>* 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.<br>* Other names: Active Ingredient BM-3103;|
| Placebo Comparator: Topical Vehicle Gel<br>Vehicle Gel | Drug: Topical Vehicle Gel<br>* 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.<br>* Other names: TolaSure Vehicle Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

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