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NCT03836287 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
A Phase 3 study, sponsored by Botanix Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
NCT03836287 is a Phase 3 study that has completed, run by Botanix Pharmaceuticals. The registered enrollment target is 350 participants.
The verdict
NCT03836287, a Phase 3 study, has completed, sponsored by Botanix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
Study Summary
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.
Interventions
- DRUG Vehicle
- DRUG Sofpironium Bromide Gel, 15%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2020-10-09 |
| Est. Completion | 2021-06-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03836287
The ClinicalTrials.gov registry entry for NCT03836287 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Botanix Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT03836287 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03836287 about?
NCT03836287 is a clinical study titled "Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)". Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Current therapies have limited effectiveness, signific...
What is the current status of trial NCT03836287?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2020-10-09. Estimated completion is 2021-06-25.
What interventions are being tested in trial NCT03836287?
The interventions under investigation include: Vehicle (DRUG), Sofpironium Bromide Gel, 15% (DRUG).
Who is sponsoring clinical trial NCT03836287?
This trial is sponsored by Botanix Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
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