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An Open Label, Phase 1, Pharmacokinetics, Maximal Usage Pharmacokinetics, Safety, and Efficacy Study of ARQ-151 Cream 0.15% Administered QD in Adolescent and Pediatric Subjects With Mild to Moderate Atopic Dermatitis

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Trial Profile

An Open Label, Phase 1, Pharmacokinetics, Maximal Usage Pharmacokinetics, Safety, and Efficacy Study of ARQ-151 Cream 0.15% Administered QD in Adolescent and Pediatric Subjects With Mild to Moderate Atopic Dermatitis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Nov 2025

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Atopic dermatitis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Arcutis Biotherapeutics

Most Recent Events

  • 06 Nov 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.
  • 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, INTEGUMENT-2 trials and INTEGUMENT-OLE and two Phase 1 pharmacokinetic studies.
  • 26 Feb 2025 According to an Arcutis Biotherapeutics media release, company announced the FDAs acceptance of a supplemental New Drug Application (sNDA) for?ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The FDA has set a PDUFA target action date of October 13, 2025 for this application

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