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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Nov 2023

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At a glance

  • Drugs Sofpironium bromide (Primary)
  • Indications Hyperhidrosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Cardigan I
  • Sponsors Botanix Pharmaceuticals; Fresh Tracks Therapeutics

    • Most Recent Events

    • 01 Apr 2023 According to a Fresh Tracks Therapeutics media release, Botanix announced the successful completion of its FDA mid-cycle review for sofpironium bromide gel, 15%. The FDA communicated to Botanix that no significant issues were identified as part of the review process, including no major clinical safety issues or risk management issues, and that there are no complex regulatory issues that might warrant an advisory committee meeting discussion. FDA approval is expected in September 2023.
    • 10 Mar 2022 According to a Brickell Biotech media release, results from this study were selected for an oral presentation at the Late-Breaking Research session during the American Academy of Dermatologys (AAD) 2022 Annual Meeting.
    • 07 Oct 2021 Primary endpoint has been met. (Gravimetric sweat production), according to a Brickell Biotech media release.
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