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NCT04088357 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants
A Phase 2 study, sponsored by BioMendics.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT04088357 is a Phase 2 study that has completed, run by BioMendics. The registered enrollment target is 72 participants.
The verdict
NCT04088357, a Phase 2 study, has completed, sponsored by BioMendics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
TolaSure is a topical gel for the promotion of accelerated wound healing. This phase II study will primarily assess the efficacy of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. Safety, cutaneous tolerability, wound pain control, and quality of healing will also be assessed. A total of 80 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will be monitored for safety and efficacy until wound closure (estimation about 8 weeks) following topical administration of TolaSure.
Interventions
- DRUG TolaSure Topical Gel
- DRUG Topical Vehicle Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2019-08-26 |
| Est. Completion | 2020-04-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04088357
The ClinicalTrials.gov registry entry for NCT04088357 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 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.
NCT04088357 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04088357 about?
NCT04088357 is a clinical study titled "Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants". TolaSure is a topical gel for the promotion of accelerated wound healing. This phase II study will primarily assess the efficacy of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. Safety, cutaneous tolerability, wound pain control, and quality of healing will al...
What is the current status of trial NCT04088357?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2019-08-26. Estimated completion is 2020-04-22.
What interventions are being tested in trial NCT04088357?
The interventions under investigation include: TolaSure Topical Gel (DRUG), Topical Vehicle Gel (DRUG).
Who is sponsoring clinical trial NCT04088357?
This trial is sponsored by BioMendics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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