Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)
Public ClinicalTrials.gov record NCT03948646. 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
- NCT03948646
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 351 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
- Dec 4, 2020 (Actual)
- Primary completion
- Aug 13, 2021 (Actual)
- Completion
- Aug 13, 2021 (Actual)
- Last update posted
- May 21, 2024
2020 – 2021
United States locations
- U.S. sites
- 42
- U.S. states
- 26
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cahaba Dermatology Skin & Health Center | Birmingham | Alabama | 35244 | — |
| Advanced Research Associates | Glendale | Arizona | 85308 | — |
| Arkansas Research Trials | North Little Rock | Arkansas | 72117 | — |
| First OC Dermatology | Fountain Valley | California | 92708 | — |
| CoDerm Research | Centennial | Colorado | 80111 | — |
| Colorado Medical Research Center | Denver | Colorado | 80210 | — |
| CCD Research, PLLC | Cromwell | Connecticut | 06416 | — |
| The GW Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Driven Research, LLC | Coral Gables | Florida | 33134 | — |
| Florida Academic Dermatology Centers Research & Education, LLC | Coral Gables | Florida | 33134 | — |
| GSI Clinical Research | Margate | Florida | 33063 | — |
| Cordova Research Institute | Miami | Florida | 33155 | — |
| MOORE Clinical Research, Inc. | Tampa | Florida | 33609 | — |
| Advanced Medical Research PC | Sandy Springs | Georgia | 30328 | — |
| DeNova Research | Chicago | Illinois | 60611 | — |
| Qualmedica Research, LLC | Evansville | Indiana | 47715 | — |
| Heartland Research Asssociates - AMR Company | Wichita | Kansas | 67205 | — |
| Delricht Research | Baton Rouge | Louisiana | 70809 | — |
| DelRicht Research | New Orleans | Louisiana | 70116 | — |
| Lupo Center for Aesthetic and General Dermatology | New Orleans | Louisiana | 70124 | — |
| Etre, Cosmetic Dermatology and Laser Center | New Orleans | Louisiana | 70130 | — |
| DermAssociates | Rockville | Maryland | 20850 | — |
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | 02472 | — |
| Michigan Center for Skin Care Research | Clinton Township | Michigan | 48038 | — |
| Hamzavi Dermatology, Inc. | Fort Gratiot | Michigan | 48059 | — |
| Saint Louis University, Department of Dermatology | St Louis | Missouri | 63122 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| JDR Dermatology Research | Las Vegas | Nevada | 89148 | — |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | — |
| SkinSearch of Rochester | Rochester | New York | 14623 | — |
| Dermatology, Laser and Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | — |
| Aventiv Research Inc. | Dublin | Ohio | 43016 | — |
| Yardley Dermatology Associates, PC | Morrisville | Pennsylvania | 19067 | — |
| Westlake Dermatology & Cosmetic Surgery | Austin | Texas | 78746 | — |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | — |
| J&S Studies, Inc. | College Station | Texas | 77845 | — |
| Modern Research Associates | Dallas | Texas | 75231 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Suzanne Bruce and Associates, P.A. | Houston | Texas | 77056 | — |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | — |
| Center for Clinical Studies, LTD.LLP | Webster | Texas | 77598 | — |
| Valley Dermatology and Skin Cancer Center | Spokane | Washington | 99216 | — |
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 NCT03948646, 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 21, 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 NCT03948646 live on ClinicalTrials.gov.