Roflumilast Foam 0.3% for Adolescent and Adult Patients with Seborrheic Dermatitis: A Randomized, Double-Blinded, Vehicle-Controlled, Phase 3 Trial.

Andrew Blauvelt,Zoe D. Draelos，David R. Berk,David H. Chu

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY（2024）

Cited 4|Views28

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 (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. 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. ( J Am Acad Dermatol 2024;90:986-93.)

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Key words

phase 3,phosphodiesterase 4 inhibitor,randomized controlled trial,roflumilast foam 0.3%,seborrheic dermatitis,STRATUM

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