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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: 20 Nov 2025

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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

  • 24 Oct 2025 Results presented in the Arcutis Biotherapeutics Media Release.
  • 06 Oct 2025 According to an Arcutis Biotherapeutics media release, based on data from this trial the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age.
  • 06 Jun 2025 According to an Arcutis Biotherapeutics media release, the data from this study will be presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, which is taking place in Nashville, TN, from June 6-7, 2025.

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