Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Public ClinicalTrials.gov record NCT03836287. 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, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 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 safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.
Study identification
- NCT ID
- NCT03836287
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 9 Years and older
- 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
- Oct 9, 2020 (Actual)
- Primary completion
- Jun 25, 2021 (Actual)
- Completion
- Jun 25, 2021 (Actual)
- Last update posted
- Jun 6, 2024
2020 – 2021
United States locations
- U.S. sites
- 39
- U.S. states
- 23
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, P.C. | Birmingham | Alabama | 35205 | — |
| Investigate MD, LLC | Scottsdale | Arizona | 85255 | — |
| Northwest Arkansas Clinical Trials Center | Rogers | Arkansas | 72758 | — |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92007 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Therapeutics Clinical Research | San Diego | California | 92123 | — |
| Clinical Science Institute | Santa Monica | California | 90404 | — |
| AboutSkin Research, LLC | Greenwood Village | Colorado | 80111 | — |
| Center for Clinical & Cosmetic Research | Aventura | Florida | 33180 | — |
| Skin Care Research, LLC | Boca Raton | Florida | 33486 | — |
| Skin Research Institute | Coral Gables | Florida | 33146 | — |
| Finlay Medical Research | Greenacres City | Florida | 33467 | — |
| Aby's New Generation Research | Hialeah | Florida | 33016 | — |
| Baumann Cosmetic and Research Institute | Miami | Florida | 33137 | — |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | — |
| My Community Research Center, Inc. | Miami | Florida | 33155 | — |
| Tory Sullivan, MD PA | North Miami Beach | Florida | 33162 | — |
| Research Institute of the Southeast | West Palm Beach | Florida | 33401 | — |
| Dawes Fretzin Research Group | Indianapolis | Indiana | 46250 | — |
| Maryland Laser Skin and Vein | Hunt Valley | Maryland | 21030 | — |
| Lawrence J Green, MD LLC | Rockville | Maryland | 20850 | — |
| SkinCare Physicians | Chestnut Hill | Massachusetts | 02467 | — |
| Grekin Skin Institute | Warren | Michigan | 48088 | — |
| Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | — |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | — |
| Skin Specialists, P.C. | Omaha | Nebraska | 68144 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| DermResearch Center of New York, Inc. | Stony Brook | New York | 11790 | — |
| PMG Research of Cary | Raleigh | North Carolina | 27518 | — |
| Haber Dermatology and Cosmetic Surgery, Inc. | Beachwood | Ohio | 44122 | — |
| Oregon Dermatology & Research Center | Portland | Oregon | 97210 | — |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29414 | — |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | — |
| DermResearch, Inc. | Austin | Texas | 78759 | — |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | — |
| Progressive Clinical Research | San Antonio | Texas | 78213 | — |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | — |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | — |
| Dermatology Associates of Seattle | Seattle | Washington | 98101 | — |
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 NCT03836287, 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 Jun 6, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03836287 live on ClinicalTrials.gov.