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A Phase 2, Open Label, 4-Week, Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

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Trial Profile

A Phase 2, Open Label, 4-Week, Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 May 2026

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Atopic dermatitis; Eczema
  • Focus Adverse reactions; Registrational
  • Acronyms INTEGUMENT-INFANT
  • Sponsors Arcutis Biotherapeutics

Most Recent Events

  • 27 Apr 2026 According to an Arcutis Biotherapeutics media release, the company announced the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA seeking to expand the indication for ZORYVE(roflumilast) cream 0.05% to include the topical treatment of mild to moderate atopic dermatitis in infants down to 3 months. The sNDA is supported by positive results from a Phase 1 open-label pharmacokinetic (PK) trial and a Phase 2 open-label trial (INTEGUMENT-INFANT).
  • 27 Apr 2026 According to an Arcutis Biotherapeutics media release, Mercedes E. Gonzalez is an INTEGUMENT-INFANT clinical trial investigator
  • 28 Mar 2026 Results published in the Media Release

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