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Background <p>The efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrated in patients with seborrheic dermatitis (SD).</p> Objectives <p>To evaluate long-term effects of roflumilast foam 0.3% in patients with SD.</p> Methods <p>A phase II, open-label trial (no. NCT04445987) was conducted in patients (aged ≥ 12 years) with SD who completed a prior roflumilast foam trial or were naïve to roflumilast and vehicle. Patients applied roflumilast foam 0.3% once daily to all affected areas, including the scalp, face, trunk, and intertriginous areas, for 24 or 52&#xa0;weeks (during the course of the trial, the protocol was amended to extend the duration of treatment from 24 weeks to 52 weeks). The primary endpoints were occurrence of treatment-emergent adverse events (AEs); local tolerability and efficacy (via Investigator Global Assessment [IGA]) were also assessed.</p> Results <p>Overall, 400 patients participated, among whom 62 were enrolled for 52 weeks. AE rates were low, and ≤ 1.1% reported stinging sensation at the application site at each visit. Durable improvement in signs and symptoms of SD was observed at weeks 24 and 52, with 76.0% and 80.4% of patients, respectively, achieving an IGA of clear or almost clear.</p> Conclusions <p>Roflumilast foam 0.3% was well tolerated and improved and/or maintained improvements in signs and symptoms of SD for up to 52 weeks.</p> ClinicalTrials.gov Listing <p>NCT04445987.</p>

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Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月1日

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  • Andrew F. Alexis,
  • Michael Bukhalo,
  • Fran E. Cook-Bolden,
  • James Q. Del Rosso,
  • Zoe D. Draelos,
  • Janet C. DuBois,
  • Laura K. Ferris,
  • Seth B. Forman,
  • Steven E. Kempers,
  • Leon H. Kircik,
  • Edward Lain,
  • Angela Y. Moore,
  • David M. Pariser,
  • Joseph Raoof,
  • Matthew J. Zirwas,
  • Melissa S. Seal,
  • Saori Kato,
  • David H. Chu,
  • David Krupa,
  • Scott Snyder,
  • Patrick Burnett,
  • David R. Berk

摘要

Background

The efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrated in patients with seborrheic dermatitis (SD).

Objectives

To evaluate long-term effects of roflumilast foam 0.3% in patients with SD.

Methods

A phase II, open-label trial (no. NCT04445987) was conducted in patients (aged ≥ 12 years) with SD who completed a prior roflumilast foam trial or were naïve to roflumilast and vehicle. Patients applied roflumilast foam 0.3% once daily to all affected areas, including the scalp, face, trunk, and intertriginous areas, for 24 or 52 weeks (during the course of the trial, the protocol was amended to extend the duration of treatment from 24 weeks to 52 weeks). The primary endpoints were occurrence of treatment-emergent adverse events (AEs); local tolerability and efficacy (via Investigator Global Assessment [IGA]) were also assessed.

Results

Overall, 400 patients participated, among whom 62 were enrolled for 52 weeks. AE rates were low, and ≤ 1.1% reported stinging sensation at the application site at each visit. Durable improvement in signs and symptoms of SD was observed at weeks 24 and 52, with 76.0% and 80.4% of patients, respectively, achieving an IGA of clear or almost clear.

Conclusions

Roflumilast foam 0.3% was well tolerated and improved and/or maintained improvements in signs and symptoms of SD for up to 52 weeks.

ClinicalTrials.gov Listing

NCT04445987.