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A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis

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Trial Profile

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Mar 2025

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms INTEGUMENT-1
  • Sponsors Arcutis Biotherapeutics

Most Recent Events

  • 17 Mar 2025 According to an Arcutis Biotherapeutics media release, Health Canada has approved PrZORYVE (roflumilast cream 0.15%), for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older. The approval of ZORYVE cream 0.15% for atopic dermatitis in Canada was supported by positive results from the vehicle-controlled pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials.
  • 07 Mar 2025 According to an Arcutis Biotherapeutics media release,positive efficacy, patient reported outcomes, and tolerability Data from INTEGUMENT-1 and INTEGUMENT-2 studies,presented at the 2025 American Academy of Dermatology Annual Meeting (AAD).
  • 07 Mar 2025 Results published in Arcutis Biotherapeutics media Release

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