Trials / Completed
CompletedNCT03620175
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- BioMendics, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TolaSure Topical Gel | TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks. |
Timeline
- Start date
- 2018-07-16
- Primary completion
- 2018-12-12
- Completion
- 2018-12-12
- First posted
- 2018-08-08
- Last updated
- 2019-01-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03620175. Inclusion in this directory is not an endorsement.