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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 is a Phase 1 study that has completed, run by BioMendics. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05062070
The ClinicalTrials.gov registry entry for NCT05062070 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 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 0 conditions, and to 2 interventions - of which TolaSure Topical Gel is the first listed.
NCT05062070 reports 0 study locations.
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.
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