Clinical Trial

Treatment of Acute Wounds

Study Description

Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - TolaSure Topical Gel

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.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT04088357

ParticipAid ID

e318xb