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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: Completed Phase 2 study, sponsored by BioMendics.
NCT04088357 is a Phase 2 study that has completed, run by BioMendics. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time-to-closure will be calculated by the number of days from biopsy to wound closure. Wound closure (changes in wound area (mm\^2) over time) will be determined by the digital imaging platform software with Principal Investigator confirmation.
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 |
What the finished NCT04088357 record still lists
NCT04088357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which TolaSure Topical Gel is the first listed.
NCT04088357 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04088357's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 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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