A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
Public ClinicalTrials.gov record NCT03627468. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Open-label, Phase 3 Long-term Safety Study of Topically Applied Sofpironium Bromide (BBI-4000) Gel, 5% and 15% in Subjects With Axillary Hyperhidrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03627468
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 9 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 5, 2018 (Actual)
- Primary completion
- Jan 27, 2020 (Actual)
- Completion
- Jan 27, 2020 (Actual)
- Last update posted
- May 19, 2023
2018 – 2020
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | — |
| Northwest Arkansas Clinical Trials Center | Rogers | Arkansas | 72758 | — |
| Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | — |
| Skin Care Research, Inc. | Boca Raton | Florida | 33486 | — |
| Baumann Cosmetic & Research Institute | Miami | Florida | 33137 | — |
| Tory Sullivan MD PA | North Miami Beach | Florida | 33162 | — |
| Research Institute of the Southeast, LLC | West Palm Beach | Florida | 33401 | — |
| Grekin Skin Institute | Warren | Michigan | 48088 | — |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | — |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | — |
| J&S Studies, Inc. | College Station | Texas | 77845 | — |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03627468, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 19, 2023 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03627468 live on ClinicalTrials.gov.