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Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex (TAMES)
TolaSure is a topical gel for the promotion of accelerated wound healing. This Phase I study will assess the safety, tolerability, and clinical effects of TolaSure when applied to wounded skin areas of patients diagnosed with severe epidermolysis bullosa simplex (i.e., EBS-Dowling Meara). A total of 10, severe EBS patients, males and females ages 18 years and older, will be enrolled. Patients will apply TolaSure and Vehicle Gel once-daily for a maximum of 10 weeks.
Details
| Lead sponsor | BioMendics, LLC |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 6 |
| Start date | Thu May 05 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Epidermolysis Bullosa Simplex
Interventions
- TolaSure Topical Gel
- Vehicle Topical Gel
Countries
United States