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Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial.
Blauvelt, Andrew; Draelos, Zoe D; Stein Gold, Linda; Alonso-Llamazares, Javier; Bhatia, Neal; DuBois, Janet; Forman, Seth B; Gooderham, Melinda; Green, Lawrence; Guenthner, Scott T; Hebert, Adelaide A; Lain, Edward; Moore, Angela Y; Papp, Kim A; Zirwas, Matthew; Kato, Saori; Snyder, Scott; Krupa, David; Burnett, Patrick; Berk, David R; Chu, David H.
Afiliación
  • Blauvelt A; Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com.
  • Draelos ZD; Dermatology Consulting Services, High Point, North Carolina.
  • Stein Gold L; Henry Ford Medical Center, Detroit, Michigan.
  • Alonso-Llamazares J; Driven Research LLC, Coral Gables, Florida.
  • Bhatia N; Therapeutics Clinical Research, San Diego, California.
  • DuBois J; DermResearch, Inc., Austin, Texas.
  • Forman SB; ForCare Medical Center, Tampa, Florida.
  • Gooderham M; SKiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough, Ontario, Canada.
  • Green L; George Washington University School of Medicine, Rockville, Maryland.
  • Guenthner ST; The Dermatology Center of Indiana, PC, Plainfield, Indiana; The Indiana Clinical Trials Center, PC, Plainfield, Indiana.
  • Hebert AA; UT Health McGovern Medical School, Houston, Texas.
  • Lain E; Sanova Dermatology, Austin, Texas.
  • Moore AY; Arlington Research Center, Arlington, Texas; Baylor University Medical Center, Dallas, Texas.
  • Papp KA; Probity Medical Research and Alliance Clinical Trials, Waterloo, Ontario, Canada; University of Toronto, Toronto, Ontario, Canada.
  • Zirwas M; Dermatologists of the Central States, Cincinnati, Ohio; Probity Medical Research, Waterloo, Ontario, Canada; Ohio University, Bexley, Ohio.
  • Kato S; Arcutis Biotherapeutics, Inc., Westlake Village, California.
  • Snyder S; Arcutis Biotherapeutics, Inc., Westlake Village, California.
  • Krupa D; Arcutis Biotherapeutics, Inc., Westlake Village, California.
  • Burnett P; Arcutis Biotherapeutics, Inc., Westlake Village, California.
  • Berk DR; Arcutis Biotherapeutics, Inc., Westlake Village, California.
  • Chu DH; Arcutis Biotherapeutics, Inc., Westlake Village, California.
J Am Acad Dermatol ; 90(5): 986-993, 2024 May.
Article en En | MEDLINE | ID: mdl-38253129
ABSTRACT

BACKGROUND:

The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions.

OBJECTIVE:

Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD).

METHODS:

In this phase 3, double-blinded trial, patients with SD were randomly assigned (21 ratio) to once-daily roflumilast foam 0.3% or vehicle foam for 8 weeks. The primary efficacy outcome was Investigator Global Assessment (IGA) Success at week 8, defined as IGA of 0 (Clear) or 1 (Almost Clear) plus ≥2-point improvement from baseline. Safety was also assessed.

RESULTS:

79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P < .001); statistically significant differences in IGA Success also favored roflumilast at week 2 (roflumilast 43.0%; vehicle 25.7%; P < .001) and week 4 (roflumilast 73.1%; vehicle 47.1%; P < .001). Roflumilast was well-tolerated with a low rate of treatment-emergent adverse events.

LIMITATIONS:

Study limitations include the 8-week treatment period for this chronic condition.

CONCLUSIONS:

Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Benzamidas / Dermatitis Seborreica Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Humans Idioma: En Revista: J Am Acad Dermatol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Benzamidas / Dermatitis Seborreica Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Humans Idioma: En Revista: J Am Acad Dermatol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos