drugset / Trial / NCT04088357

Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

NCT04088357 ↗

Phase 2 Completed 72 enrolled BioMendics, LLC Symbio, LLC · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2019-08-26
Primary completion
2020-04-22
Completion
2020-04-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator TolaSure Unknown 5 % Topical

Indications

No indication recorded.