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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: Completed Phase 2 study, sponsored by Botanix Pharmaceuticals.
NCT03785587 is a Phase 2 study that has completed, run by Botanix Pharmaceuticals. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.
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 |
What the finished NCT03785587 record still lists
NCT03785587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Sofpironium Bromide Gel, 15% is the first listed.
NCT03785587 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03785587's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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