Axillary Hyperhidrosis Clinical Trial
— Cardigan IIOfficial 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
Verified date | December 2022 |
Source | Botanix Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 351 |
Est. completion date | August 13, 2021 |
Est. primary completion date | August 13, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years and older |
Eligibility | Inclusion Criteria: - Male or female subject = 9 years of age. - Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4 and (c) a minimum GSP of 50 mg is each axilla with a combined total of at least 150 mg. - The ability to understand and follow all study-related procedures including study drug administration. - Sexually active female of childbearing potential (FOCBP)* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product. Exclusion Criteria: - In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(s). - Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis. - Anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration. - Use of any cholinergic drug (e.g. bethanechol) within 28 days. - Known cause of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.). - Subjects with unstable diabetes mellitus or thyroid disease, history of renal or hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions, Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate sweat production by the use of anticholinergics in the investigator's opinion. - Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation. - Subject is pregnant, lactating or is planning to become pregnant during the study. |
Country | Name | City | State |
---|---|---|---|
United States | Westlake Dermatology & Cosmetic Surgery | Austin | Texas |
United States | Delricht Research | Baton Rouge | Louisiana |
United States | Bellaire Dermatology Associates | Bellaire | Texas |
United States | Cahaba Dermatology Skin & Health Center | Birmingham | Alabama |
United States | CoDerm Research | Centennial | Colorado |
United States | Dermatology, Laser and Vein Specialists of the Carolinas | Charlotte | North Carolina |
United States | DeNova Research | Chicago | Illinois |
United States | Michigan Center for Skin Care Research | Clinton Township | Michigan |
United States | J&S Studies, Inc. | College Station | Texas |
United States | Driven Research, LLC | Coral Gables | Florida |
United States | Florida Academic Dermatology Centers Research & Education, LLC | Coral Gables | Florida |
United States | CCD Research, PLLC | Cromwell | Connecticut |
United States | Modern Research Associates | Dallas | Texas |
United States | Colorado Medical Research Center | Denver | Colorado |
United States | Aventiv Research Inc. | Dublin | Ohio |
United States | Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey |
United States | Qualmedica Research, LLC | Evansville | Indiana |
United States | Hamzavi Dermatology, Inc. | Fort Gratiot | Michigan |
United States | First OC Dermatology | Fountain Valley | California |
United States | Advanced Research Associates | Glendale | Arizona |
United States | Suzanne Bruce and Associates, P.A. | Houston | Texas |
United States | University of Texas Health Science Center at Houston | Houston | Texas |
United States | JDR Dermatology Research | Las Vegas | Nevada |
United States | GSI Clinical Research | Margate | Florida |
United States | Cordova Research Institute | Miami | Florida |
United States | Yardley Dermatology Associates, PC | Morrisville | Pennsylvania |
United States | DelRicht Research | New Orleans | Louisiana |
United States | Etre, Cosmetic Dermatology and Laser Center | New Orleans | Louisiana |
United States | Lupo Center for Aesthetic and General Dermatology | New Orleans | Louisiana |
United States | Arkansas Research Trials | North Little Rock | Arkansas |
United States | Meridian Clinical Research, LLC | Omaha | Nebraska |
United States | SkinSearch of Rochester | Rochester | New York |
United States | DermAssociates | Rockville | Maryland |
United States | Saint Louis University, Department of Dermatology | Saint Louis | Missouri |
United States | Dermatology Clinical Research Center of San Antonio | San Antonio | Texas |
United States | Advanced Medical Research PC | Sandy Springs | Georgia |
United States | Valley Dermatology and Skin Cancer Center | Spokane | Washington |
United States | MOORE Clinical Research, Inc. | Tampa | Florida |
United States | The GW Medical Faculty Associates | Washington | District of Columbia |
United States | Bay State Clinical Trials, Inc. | Watertown | Massachusetts |
United States | Center for Clinical Studies, LTD.LLP | Webster | Texas |
United States | Heartland Research Asssociates - AMR Company | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Botanix Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of participants with treatment emergent adverse events | Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe | Through study completion (6 weeks). | |
Primary | Change in Hyperhidrosis Disease Severity Measure-Axillary score | Change in score from baseline to end of treatment of an 11 question patient reported outcome assessment, each question has a 5 point response (range 0 [better] - 4 [worse]). | 6 weeks | |
Primary | Gravimetric sweat production | Change in the measured weight of axillary sweat production from baseline to end of study. | 6 weeks |
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