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

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...

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Published in:Journal of the American Academy of Dermatology 2024-05, Vol.90 (5), p.986-993
Main Authors: 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.
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Language:English
Subjects:
phase 3
phosphodiesterase 4 inhibitor
randomized controlled trial
roflumilast foam 0.3
seborrheic dermatitis
STRATUM
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creator 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.
description 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 
doi_str_mv 10.1016/j.jaad.2023.12.065
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subjects phase 3
phosphodiesterase 4 inhibitor
randomized controlled trial
roflumilast foam 0.3
seborrheic dermatitis
STRATUM
title Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial
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