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NCT03785587 · ClinicalTrials.gov registry record · Phase 2
A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
A Phase 2 study, sponsored by Botanix Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03785587 is a Phase 2 study that has completed, run by Botanix Pharmaceuticals. The registered enrollment target is 21 participants.
The verdict
NCT03785587, a Phase 2 study, has completed, sponsored by Botanix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 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. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.
Interventions
- DRUG Sofpironium Bromide Gel, 15%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2019-09-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03785587
The ClinicalTrials.gov registry entry for NCT03785587 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 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 1 intervention - of which Sofpironium Bromide Gel, 15% is the first listed.
NCT03785587 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03785587 about?
NCT03785587 is a clinical study titled "A Safety Study of BBI-4000 Gel in Pediatric 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. Sofpironium bromide (BBI-4000) is a novel soft-drug in ...
What is the current status of trial NCT03785587?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2018-12-21. Estimated completion is 2019-09-06.
What interventions are being tested in trial NCT03785587?
The interventions under investigation include: Sofpironium Bromide Gel, 15% (DRUG).
Who is sponsoring clinical trial NCT03785587?
This trial is sponsored by Botanix Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
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