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Roflumilast Foam 0.3%
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells.
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells. Used for Atopic dermatitis (topical foam formulation), Plaque psoriasis (topical foam formulation).
At a glance
| Generic name | Roflumilast Foam 0.3% |
|---|---|
| Also known as | ARQ-154, ARQ-154 0.3% |
| Sponsor | Arcutis Biotherapeutics, Inc. |
| Drug class | Phosphodiesterase-4 (PDE-4) inhibitor |
| Target | PDE-4 |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting PDE-4, roflumilast prevents the breakdown of cyclic adenosine monophosphate (cAMP) in inflammatory cells such as macrophages and T cells, leading to decreased production of pro-inflammatory cytokines and chemokines. This mechanism reduces skin inflammation and is particularly effective in conditions characterized by excessive immune activation. The foam formulation allows for topical delivery to affected skin areas.
Approved indications
- Atopic dermatitis (topical foam formulation)
- Plaque psoriasis (topical foam formulation)
Common side effects
- Application site irritation
- Application site burning
- Headache
- Nausea
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
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |