Details

Autor(en) / Beteiligte

• 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.

Titel

Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial

Ist Teil von

• Journal of the American Academy of Dermatology, 2024-05, Vol.90 (5), p.986-993

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2024

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions. Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD). In this phase 3, double-blinded trial, patients with SD were randomly assigned (2:1 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. 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. Study limitations include the 8-week treatment period for this chronic condition. 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.