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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: Completed Phase 3 study, sponsored by Botanix Pharmaceuticals.
NCT03836287 is a Phase 3 study that has completed, run by Botanix Pharmaceuticals. The registered enrollment target is 350 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 \[better\] - 4 \[worse\]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline
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 |
What the finished NCT03836287 record still lists
NCT03836287 is an interventional study that assigns participants to a tested intervention. The registered 350 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 (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT03836287 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03836287's enrollment target sits among peer trials
350 1034th of 2000 higher than 956 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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