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: 09 Apr 2018

At a glance

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

    • 09 Apr 2018 Results published in the Ortho Dermatologics Media Release
    • 31 Mar 2018 Results (n=418) of pooled data from two trials (study 301 and 302) assessing safety and efficacy of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis, were published in the Journal of the American Academy of Dermatology.
    • 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.
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