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

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

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.

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