A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Trial Profile

A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Nov 2017

At a glance

  • Drugs Tazarotene/ulobetasol (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Valeant Pharmaceuticals International
  • Most Recent Events

    • 02 Nov 2017 According to an Ortho Dermatologics media release, U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for plaque psoriasis.The PDUFA action date is June 18, 2018.
    • 26 Oct 2017 Status changed from active, no longer recruiting to completed.
    • 05 Sep 2017 Primary endpoint has been met. (The percent of subjects with treatment success), as reported by an Ortho Dermatologics Media Release.
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