Status:
COMPLETED
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Lead Sponsor:
Botanix Pharmaceuticals
Conditions:
Axillary Hyperhidrosis
Eligibility:
All Genders
9+ years
Phase:
PHASE3
Brief Summary
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 overacti...
Detailed Description
This is a multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide, 15% gel in subjects with axillary hyperhidrosis....
Eligibility Criteria
Inclusion
- Male or female subject ≥ 9 years of age.
- Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhidrosis 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
- 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.
Key Trial Info
Start Date :
October 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2021
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT03836287
Start Date
October 9 2020
End Date
June 25 2021
Last Update
June 6 2024
Active Locations (39)
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1
Total Skin and Beauty Dermatology Center, P.C.
Birmingham, Alabama, United States, 35205
2
Investigate MD, LLC
Scottsdale, Arizona, United States, 85255
3
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States, 72758
4
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92007