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NCT03627468 · ClinicalTrials.gov registry record · Phase 3
A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
A Phase 3 study, sponsored by Botanix Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT03627468 is a Phase 3 study that has completed, run by Botanix Pharmaceuticals. The registered enrollment target is 300 participants.
The verdict
NCT03627468, a Phase 3 study, has completed, sponsored by Botanix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 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 long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.
Interventions
- DRUG Sofpironium Bromide Gel, 15%
- DRUG Sofpironium Bromide Gel, 5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2020-01-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03627468
The ClinicalTrials.gov registry entry for NCT03627468 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 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 Sofpironium Bromide Gel, 15% is the first listed.
NCT03627468 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03627468 about?
NCT03627468 is a clinical study titled "A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis". 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, significa...
What is the current status of trial NCT03627468?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2018-09-05. Estimated completion is 2020-01-27.
What interventions are being tested in trial NCT03627468?
The interventions under investigation include: Sofpironium Bromide Gel, 15% (DRUG), Sofpironium Bromide Gel, 5% (DRUG).
Who is sponsoring clinical trial NCT03627468?
This trial is sponsored by Botanix Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
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