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

Patient is a male or female at least 2 years of age.

Patient has a documented diagnosis and confirmed clinical history of localized (previously known as Weber-Cockayne), intermediate (previously Kӧbner), or severe (previously EBS-Dowling Meara) autosomal dominant EBS and/or a genetic mutation in either the KRT14 or KRT5 gene consistent with localized, intermediate, or severe EBS. The Investigator will determine patient eligibility based on historical phenotypic presentation of EBS symptoms along with genetic/diagnosis documentation to determine EBS severity. (If localized, intermediate, or severe EBS is suspected but not diagnosed or genetically confirmed, confirmatory testing will be performed).

Patient must have at least moderate plantar disease activity, defined as ≥15% involvement of the plantar surface of at least one foot, as assessed by clinical examination or standardized imaging, with evidence of active disease (e.g., blisters, erosions, or crusting).

For treatment, the Target Lesional Area (TLA) will consist of daily treating the feet (tops and bottoms) which is approximately 7% body surface area (BSA). Localized EBS subjects will also have the option to treat their hands (tops and bottoms), which is approximately an additional 6% BSA. Palmoplantar evaluation is separate from the intermediate to severe TLA-treated regions per protocol.