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

Trial Profile

A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Ointment to the Vehicle in Adult 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

  • 25 Oct 2021 Results published in the Journal of the American Academy of Dermatology
  • 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.
  • 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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