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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: Completed Phase 3 study, sponsored by Botanix Pharmaceuticals.
NCT03627468 is a Phase 3 study that has completed, run by Botanix Pharmaceuticals. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of participants with treatment emergent adverse events cumulative to week 48 by maximum severity based on a 3 point increasing severity scale of: mild, moderate and severe
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 |
What the finished NCT03627468 record still lists
NCT03627468 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Sofpironium Bromide Gel, 15% is the first listed.
NCT03627468 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03627468's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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