Condition: Epidermolysis Bullosa Simplex · Sponsor: BioMendics, LLC
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Stanford University School of Medicine, Dermatology Department | Palo Alto, California, United States | Recruiting |
| NU Dermatolgy CTU | Chicago, Illinois, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07027345