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Roflumilast Foam

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammation by increasing intracellular cAMP levels in immune and inflammatory cells.

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammation by increasing intracellular cAMP levels in immune and inflammatory cells. Used for Atopic dermatitis (topical foam formulation), Plaque psoriasis (topical foam formulation).

At a glance

Mechanism of action

By inhibiting PDE-4, roflumilast prevents the breakdown of cyclic adenosine monophosphate (cAMP), leading to elevated cAMP levels in macrophages, neutrophils, and other inflammatory cells. This suppresses the production of pro-inflammatory cytokines and chemokines, reducing overall inflammatory responses. The foam formulation is designed for topical delivery to affected skin areas in inflammatory dermatological conditions.

Approved indications

• Atopic dermatitis (topical foam formulation)
• Plaque psoriasis (topical foam formulation)

Common side effects

• Application site irritation
• Headache
• Nausea
• Diarrhea

Key clinical trials

• The Safety and Efficacy of Roflumilast Foam in HS (PHASE2)
• A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa (PHASE2)
• An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV) (PHASE2)
• Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR) (PHASE3)
• Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM) (PHASE3)
• Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis (PHASE2)
• Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis (PHASE2)

Primary sources

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