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

BioMendics

Status and phase: Completed; Phase 1

Conditions: Wound Healing

Treatments: Drug: TolaSure Topical Gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03620175

20180394

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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22 participants in 4 patient groups, including a placebo group

5 Percent TolaSure Topical Gel

Active Comparator group

Treatment:

Drug: TolaSure Topical Gel

1.5 Percent TolaSure Topical Gel

Active Comparator group

Treatment:

Drug: TolaSure Topical Gel

0.5 Percent TolaSure Topical Gel

Active Comparator group

Treatment:

Drug: TolaSure Topical Gel

Topical Vehicle Gel

Placebo Comparator group

Treatment:

Drug: TolaSure Topical Gel