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A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis

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Trial Profile

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Aug 2024

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Atopic dermatitis
  • Focus Adverse reactions; Registrational
  • Acronyms INTEGUMENT-OLE
  • Sponsors Arcutis Biotherapeutics

    • Most Recent Events

    • 28 Aug 2024 Results published in an Arcutis Biotherapeutics media release.
    • 28 Aug 2024 According to an Arcutis Biotherapeutics media release, today announced results from the INTEGUMENT-OLE long-term open-label study of once-daily roflumilast cream 0.05% demonstrating the durable efficacy and favorable safety profile of roflumilast cream 0.05% in the treatment of mild to moderate AD in children 2 to 5 years old.
    • 10 Jun 2024 According to an Arcutis Biotherapeutics media release, Melinda Gooderham is investigator in this trial.

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