A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex

This Phase II clinical study will assess the efficacy, safety and tolerability of topical TolaSure Gel in adults and pediatric patients (2 years of age and older) diagnosed with localized, intermediate, or 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. Localized patients will be applying study medication to their feet, with the option to treat their hands as well throughout the study. Intermediate and severe EBS 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.

NCT Number	NCT07027345
Lead Sponsor	BioMendics, LLC Collaborators: Northwestern University, Ann & Robert H Lurie Children's Hospital of Chicago, Stanford University, Lucile Packard Children's Hospital
Conditions	Epidermolysis Bullosa Simplex
Enrollment	40 participants
Start Date	2025-09-11
Primary Completion	2027-01 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-13