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NCT03620175 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Topical TolaSure on Skin Punch Biopsies in Healthy Participants
A Phase 1 study of Wound Healing, sponsored by BioMendics.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT03620175: Completed Phase 1 study of Wound Healing, sponsored by BioMendics.
NCT03620175 is a Phase 1 study of Wound Healing that has completed, run by BioMendics. The registered enrollment target is 22 participants, below the 56-participant average among 11 other Wound Healing trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03620175, a Phase 1 study of Wound Healing, has completed, sponsored by BioMendics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
TolaSure is a topical gel for the promotion of wound healing. This phase I study will assess the safety, tolerability and clinical effect of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. A total of 26 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will monitored for safety and efficacy over the course of 2 weeks following daily topical administration of TolaSure.
Primary Outcome
Absolute values and changes over time of clinical chemistries including; Absolute values and changes over time of clinical blood and urine chemistries including; Hematology and Coagulation, Coagulation, Serum Chemistry, and Urinalysis. Blood and urine analytes are measured on a per mL basis.
Conditions Studied
Interventions
- DRUG TolaSure Topical Gel
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2018-12-12 |
| Phase | Phase 1 |
What the finished NCT03620175 record still lists
NCT03620175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 56-participant average among 11 other Wound Healing trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Wound Healing appearing as the primary indexed condition, and to 1 intervention - of which TolaSure Topical Gel is the first listed.
NCT03620175 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03620175 about?
NCT03620175 is a clinical study titled "Safety and Efficacy of Topical TolaSure on Skin Punch Biopsies in Healthy Participants". TolaSure is a topical gel for the promotion of wound healing. This phase I study will assess the safety, tolerability and clinical effect of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. A total of 26 healthy volunteers, males and females ages 18 years or olde...
What is the current status of trial NCT03620175?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2018-07-16. Estimated completion is 2018-12-12.
What conditions does trial NCT03620175 study?
This clinical trial studies the following conditions: Wound Healing.
What interventions are being tested in trial NCT03620175?
The interventions under investigation include: TolaSure Topical Gel (DRUG).
Who is sponsoring clinical trial NCT03620175?
This trial is sponsored by BioMendics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03620175 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03620175's enrollment target sits among peer trials
22 10th of 11 higher than 2 of 11 other Wound Healing trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wound Healing 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.
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