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NCT07027345 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex
A Phase 2 study of Epidermolysis Bullosa Simplex, sponsored by BioMendics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT07027345 is a Phase 2 study of Epidermolysis Bullosa Simplex that is actively recruiting participants, run by BioMendics. The registered enrollment target is 40 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT07027345, a Phase 2 study of Epidermolysis Bullosa Simplex, is actively recruiting participants, sponsored by BioMendics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- DRUG 5% TolaSure Topical Gel
- DRUG Topical Placebo Gel
Study Locations (2)
California
- Stanford University School of Medicine, Dermatology Department - Palo Alto
Illinois
- NU Dermatolgy CTU - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-09 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07027345
The ClinicalTrials.gov registry entry for NCT07027345 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMendics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Epidermolysis Bullosa Simplex appearing as the primary indexed condition, and to 2 interventions - of which 5% TolaSure Topical Gel is the first listed.
NCT07027345 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Illinois.
Frequently Asked Questions
What is clinical trial NCT07027345 about?
NCT07027345 is a clinical study titled "A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex". 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 ...
What is the current status of trial NCT07027345?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-09. Estimated completion is 2026-09.
What conditions does trial NCT07027345 study?
This clinical trial studies the following conditions: Epidermolysis Bullosa Simplex.
What interventions are being tested in trial NCT07027345?
The interventions under investigation include: 5% TolaSure Topical Gel (DRUG), Topical Placebo Gel (DRUG).
Who is sponsoring clinical trial NCT07027345?
This trial is sponsored by BioMendics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07027345 being conducted?
This trial has 2 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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