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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: 23 Mar 2025

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Atopic dermatitis
  • Focus Adverse reactions; Pharmacokinetics
  • 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, 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
  • 18 Oct 2024 According to an Arcutis Biotherapeutics media release, the company has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older.

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