NCT04088357

Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: BioMendics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Wound Healing

Interventions

Type	Name	Description
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.
DRUG	Topical Vehicle Gel	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.

Timeline

• Start date: 2019-08-26
• Primary completion: 2020-04-22
• Completion: 2020-04-22
• First posted: 2019-09-12
• Last updated: 2021-06-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study