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

Study acronym: (TAMES)
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 2025 → Jan 2027
See other at-risk trials from BioMendics, LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2025 to Jan 2027v3 Show 5 more changesShow less
    • Study completion pushed from Sep 2026 to Sep 2027
    • Start date changed from estimate of Sep 2025 to Sep 11, 2025
    • Eligibility criteria expanded, about 149 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Study description expanded, about 188 words
  2. Site contacts updated at 1 of 2 sitesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Epidermolysis Bullosa Simplex
Related terms Epidermolysis Bullosa, Epidermolysis Bullosa Simplex, Skin Abnormalities, Skin Diseases
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov