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A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis

Trial Profile

A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Jan 2024

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Seborrhoeic dermatitis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Arcutis Biotherapeutics

Most Recent Events

  • 08 Jan 2024 According to an Arcutis Biotherapeutics media release, based on results from STRATUM and the Phase 2 Trial 203, the Health Canada has accepted for review the Supplement to a New Drug Submission (SNDS) for roflumilast foam 0.3%, a steroid-free, once-daily phosphodiesterase-4 (PDE4) inhibitor for the topical treatment of seborrheic dermatitis in adult and adolescent patients 9 years of age and older.
  • 15 Dec 2023 According to an Arcutis Biotherapeutics media release, based on results from STRATUM and the Phase 2 Trial 203, the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older.
  • 03 May 2023 Results assessing safety and efficacy of roflumilast foam in seborrheic dermatitis patients were published in the JAMA Dermatology

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