Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07027345
PHASE2

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

Sponsor: BioMendics, LLC

View on ClinicalTrials.gov

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.

Official title: A Phase II, Closed Label, Placebo Controlled, Randomized, Double-Blinded Clinical Trial to Evaluate the Efficacy and Safety of TolaSure Gel, 5% w/w Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex (TAMES)

Key Details

Gender

All

Age Range

4 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09

Completion Date

2026-09

Last Updated

2025-09-11

Healthy Volunteers

No

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).

Locations (2)

Stanford University School of Medicine, Dermatology Department

Palo Alto, California, United States

NU Dermatolgy CTU

Chicago, Illinois, United States