Axillary Hyperhidrosis Clinical Trial
— Cardigan IOfficial 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 | February 2024 |
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 | 350 |
Est. completion date | June 25, 2021 |
Est. primary completion date | June 25, 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 in 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(e). - 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 | DermResearch, Inc. | Austin | Texas |
United States | Center for Clinical & Cosmetic Research | Aventura | Florida |
United States | Haber Dermatology and Cosmetic Surgery, Inc. | Beachwood | Ohio |
United States | Hassman Research Institute | Berlin | New Jersey |
United States | Total Skin and Beauty Dermatology Center, P.C. | Birmingham | Alabama |
United States | Skin Care Research, LLC | Boca Raton | Florida |
United States | Clinical Research Center of the Carolinas | Charleston | South Carolina |
United States | SkinCare Physicians | Chestnut Hill | Massachusetts |
United States | Skin Research Institute | Coral Gables | Florida |
United States | California Dermatology & Clinical Research Institute | Encinitas | California |
United States | Finlay Medical Research | Greenacres City | Florida |
United States | AboutSkin Research, LLC | Greenwood Village | Colorado |
United States | Aby's New Generation Research | Hialeah | Florida |
United States | Maryland Laser Skin and Vein | Hunt Valley | Maryland |
United States | Dawes Fretzin Research Group | Indianapolis | Indiana |
United States | Dermatology Research Associates | Los Angeles | California |
United States | Baumann Cosmetic and Research Institute | Miami | Florida |
United States | International Dermatology Research, Inc. | Miami | Florida |
United States | My Community Research Center, Inc. | Miami | Florida |
United States | Tennessee Clinical Research Center | Nashville | Tennessee |
United States | Minnesota Clinical Study Center | New Brighton | Minnesota |
United States | Virginia Clinical Research, Inc. | Norfolk | Virginia |
United States | Tory Sullivan, MD PA | North Miami Beach | Florida |
United States | Skin Specialists, P.C. | Omaha | Nebraska |
United States | Austin Institute for Clinical Research, Inc. | Pflugerville | Texas |
United States | Oregon Dermatology & Research Center | Portland | Oregon |
United States | PMG Research of Cary | Raleigh | North Carolina |
United States | Lawrence J Green, MD LLC | Rockville | Maryland |
United States | Northwest Arkansas Clinical Trials Center | Rogers | Arkansas |
United States | MediSearch Clinical Trials | Saint Joseph | Missouri |
United States | Progressive Clinical Research | San Antonio | Texas |
United States | Texas Dermatology and Laser Specialists | San Antonio | Texas |
United States | Therapeutics Clinical Research | San Diego | California |
United States | Clinical Science Institute | Santa Monica | California |
United States | Investigate MD, LLC | Scottsdale | Arizona |
United States | Dermatology Associates of Seattle | Seattle | Washington |
United States | DermResearch Center of New York, Inc. | Stony Brook | New York |
United States | Grekin Skin Institute | Warren | Michigan |
United States | Research Institute of the Southeast | West Palm Beach | Florida |
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 (mg) of axillary (right+left axillae) sweat production from baseline to end of study. | 6 weeks |
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