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A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2023

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At a glance

  • Drugs Clascoterone (Primary) ; Clascoterone (Primary)
  • Indications Acne vulgaris
  • Focus Registrational; Therapeutic Use
  • Sponsors Cassiopea

    • Most Recent Events

    • 19 Jun 2023 According to Sun Pharmaceutical Industries Limited media release, the company has announced Health Canada's approval of WINLEVI (clascoterone cream 1%) for the topical treatment of acne vulgaris (acne) in patients 12 years of age and older, and the newest Health Canada-approved formulation to target the hormonal component of acne for Canadian patients in 40 years.
    • 21 Mar 2023 Results from CB03-01-25, CB03-01-26, CB03-01-27 assessing Safety , presented at the American Academy of Dermatology annual Meeting 2023
    • 25 Mar 2022 Primary endpoint (Success rate in Investigators Global Assessment (IGA)) has been met as per Sun Pharmaceutical Industries Limited media release

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