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

NCT07027345 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-11

No results posted yet for this study

Summary

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.

Conditions

  • Epidermolysis Bullosa Simplex

Interventions

DRUG

5% TolaSure Topical Gel

TolaSure Topical Gel is applied once-daily to designated treatment areas for up to 4 months (Part 2 End of Study).

DRUG

Topical Placebo Gel

Topical Placebo Gel is applied once-daily to designated treatment areas for up to 2 months (Part 1 End of Study).

Sponsors & Collaborators

  • Northwestern University Feinberg School of Medicine

    collaborator OTHER

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Lucile Packard Children's Hospital

    collaborator OTHER

  • BioMendics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2025-12-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07027345 on ClinicalTrials.gov