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A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment to the Vehicle in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)

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Trial Profile

A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment to the Vehicle in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2021

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At a glance

  • Drugs Difamilast (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical

    • Most Recent Events

    • 27 Sep 2021 According to a Ostuka Pharmaceutical Co., Ltd. media release, Moizerto Ointment (difamilast) has received manufacturing and marketing approval in Japan for the indication of adult and pediatric (two years of age and older) atopic dermatitis.
    • 12 Jul 2021 Results assessing superiority of topical difamilast to vehicle in Japanese paediatric patients with AD published in the British Journal of Dermatology
    • 25 Apr 2021 Results assessing efficacy and safety of a topical difamilast ointment, in adult and pediatric patients with atopic dermatitis from two phase 3 studies (NCT0390897 & NCT03911401), presented at the American Academy of Dermatology Virtual Meeting Experience 2021.
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