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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: Recruiting Phase 2 study of Epidermolysis Bullosa Simplex, sponsored by BioMendics.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical photography will be used to assess changes in disease severity within the target lesional area (TLA) and recurrence of blistering by measuring blister surface area in the designated TLA over time.
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 |
What NCT07027345 shows while recruiting
NCT07027345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT07027345's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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