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Study: Roflumilast Foam Safe, Effective for Scalp and Body Psoriasis


New data on the safety and efficacy of roflumilast foam (ARQ-154, Arcutis Biotherapeutics) for scalp and body psoriasis was presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.

Roflumilast foam (ARQ-154, Arcutis Biotherapeutics) demonstrated safety and efficacy in improving scalp and body psoriasis, according to a late-breaking oral presentation at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.1

Roflumilast foam is an investigational once-daily, topical phosphodiesterase-4 (PDE4) inhibitor.

“Many current treatment options for psoriasis often carry significant limitations, particularly when being used to treat body areas covered with hair, which result in poor outcomes and additional patient burden,” said lead investigator Leon Kircik, MD, clinical professor of dermatology at Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and medical director at Physicians Skin Care, DermResearch, and Skin Sciences in Louisville, Kentucky.

He added, “Roflumilast once-daily foam, a novel formulation specifically designed for use on hair-bearing areas of the body like the scalp, but usable on all areas of the body, demonstrated significant benefit on both scalp and non-scalp areas. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, be used in all areas of the body, and ultimately improve the patient experience.”

New data from the phase 2b study demonstrated that the topical significantly improved scalp and body psoriasis in as early as 2 weeks of treatment.

The primary endpoint of the study was a Scalp Investigator’s Global Assessment (S-IGA) success defined as a score of clear/almost clear and ≥2-grade reduction from baseline at Week 8.

The primary endpoint was achieved by 59.1% of roflumilast foam patients compared to 11.4% of vehicle (P<0.0001). Additionally, investigators found that 34.3% of patients treated with roflumilast foam and 3.4% of those treated with vehicle rated clear at Week 8.

Also, Body IGA success at Week was achieved by 40.3% roflumilast foam and 6.8% vehicle, respectively (P<0.0001).

The topical was well-tolerated in the study, with incidence of treatment-related adverse events (TEAEs), application site adverse events (AEs), and discontinuations due to AEs all being low and similar to vehicle.

The most common TEAEs included the following:

  • Application site pain (1.0% roflumilast foam vs. 3.8% vehicle)
  • Diarrhea (1.5% vs. 0%)
  • COVID-19 (1.5% vs. 1.9%)
  • Sinusitis (0.5% vs. 1.9%)
  • Psoriasis (0.5% vs. 1.9%)
  • Hypertension (1.5% vs. 1.0%)

Discontinuation due to AEs was 2.5% roflumilast foam and 1.9% vehicle. Also, no patients in either group experienced any serious AEs in the study.

Arcutis also presented new data on roflumilast foam and cream (ARQ-151) for the treatment of seborrheic dermatitis and mild to severe chronic plaque psoriasis, as well as its impact on itch and use for steroid-sensitive areas.

“Psoriasis and seborrheic dermatitis can significantly impact quality of life and are very challenging to treat, particularly long-term,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis Biotherapeutics in Westlake Village, California. “These new data add to the growing body of evidence supporting the potential of roflumilast, if approved, as an important, new treatment option for people affected by these chronic dermatological conditions.”


1. Arcutis biotherapeutics showcases new roflumilast data in psoriasis and seborrheic dermatitis at american academy of dermatology (Aad) virtual meeting experience (Vmx) 2021. GlobeNewswire News Room. Published April 23, 2021. Accessed April 24, 2021. https://www.globenewswire.com/news-release/2021/04/23/2216077/0/en/Arcutis-Biotherapeutics-Showcases-New-Roflumilast-Data-in-Psoriasis-and-Seborrheic-Dermatitis-at-American-Academy-of-Dermatology-AAD-Virtual-Meeting-Experience-VMX-2021.html

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