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.
    • 05 Sep 2017 Primary endpoint has been met. (The percent of subjects with treatment success), as reported by an Ortho Dermatologics Media Release.
    • 05 Sep 2017 According to an Ortho Dermatologics media release, based on the data from this and other trial (see profile 257590), the company has submitted a New Drug Application (NDA) to the U.S. FDA for IDP-118 (halobetasol propionate and tazarotene) lotion for the treatment of plaque psoriasis.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top