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A Phase II, Closed Label, Placebo Controlled, Randomized, Double-Blinded Clinical Trial to Evaluate the Efficacy and Safety of TolaSure Gel, 5% w/w Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex (TAMES)
This Phase II clinical study will assess the efficacy, safety and tolerability of topical TolaSure Gel in adults and pediatric patients (4 years of age and older) diagnosed with generalized intermediate to severe epidermolysis bullosa simplex (EBS). Each patient (40 to complete) will be enrolled in the study and will be randomized to receive either TolaSure Gel or a topical Placebo for daily application for 2-months. After 2-months, all patients will receive TolaSure Gel to daily apply for an additional 2-months. A remote follow-up visit will occur 2-months after the end of study. Total time in the study is 6-months. Patients will be applying study medication to randomized treatment area(s) (a minimum of \~2-3% Body Surface Area (BSA)), with the option to treat their feet as well throughout the study.
Details
| Lead sponsor | BioMendics, LLC |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 40 |
| Start date | 2025-09 |
| Completion | 2026-09 |
Conditions
- Epidermolysis Bullosa Simplex
Interventions
- 5% TolaSure Topical Gel
- Topical Placebo Gel
Primary outcomes
- Change in Blister Surface Area of the Designated Treatment Area(s) — Day 1 (Baseline) and weekly until End of Study (2-months and maximum 4-months)
Clinical photography will be used to assess changes in disease severity within the target lesional area (TLA) and recurrence of blistering by measuring blister surface area in the designated TLA over time.
Countries
United States