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NCT05062070 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex
A Phase 1 study, sponsored by BioMendics.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT05062070: Completed Phase 1 study, sponsored by BioMendics.
NCT05062070 is a Phase 1 study that has completed, run by BioMendics. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05062070, a Phase 1 study, has completed, sponsored by BioMendics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
TolaSure is a topical gel for the promotion of accelerated wound healing. This Phase I study will assess the safety, tolerability, and clinical effects of TolaSure when applied to wounded skin areas of patients diagnosed with severe epidermolysis bullosa simplex (i.e., EBS-Dowling Meara). A total of 10, severe EBS patients, males and females ages 18 years and older, will be enrolled. Patients will apply TolaSure and Vehicle Gel once-daily for a maximum of 10 weeks.
Primary Outcome
Safety monitoring will include clinical chemistry tests, physical examinations (including assessment of Treatment and Suction Blister Areas), and vital sign measurements. These assessments along with AE reviews will identify potential TEAEs.
Interventions
- DRUG TolaSure Topical Gel
- DRUG Vehicle Topical Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-05-05 |
| Est. Completion | 2023-06-22 |
| Phase | Phase 1 |
What the finished NCT05062070 record still lists
NCT05062070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which TolaSure Topical Gel is the first listed.
NCT05062070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05062070 about?
NCT05062070 is a clinical study titled "Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex". TolaSure is a topical gel for the promotion of accelerated wound healing. This Phase I study will assess the safety, tolerability, and clinical effects of TolaSure when applied to wounded skin areas of patients diagnosed with severe epidermolysis bullosa simplex (i.e., EBS-Dowling Meara). A total of...
What is the current status of trial NCT05062070?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2022-05-05. Estimated completion is 2023-06-22.
What interventions are being tested in trial NCT05062070?
The interventions under investigation include: TolaSure Topical Gel (DRUG), Vehicle Topical Gel (DRUG).
Who is sponsoring clinical trial NCT05062070?
This trial is sponsored by BioMendics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05062070's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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