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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: 17 Sep 2026

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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

  • 20 Aug 2026 According to an Arcutis Biotherapeutics media release, company announced that Health Canada has approved PrZORYVE (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis (AD) in pediatric patients 2 to 5 years of age.
  • 28 Mar 2026 According to an Arcutis Biotherapeutics media release, full results of INTEGUMENT-OLE published in the journal Pediatric Dermatology earlier this month.
  • 28 Mar 2026 According to an Arcutis Biotherapeutics media release, data from the trial were presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, CO.

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