Roflumilast Topical Foam 0.3% Approved to Treat Plaque Psoriasis in People Aged 12 Years and Older

The FDA today approved roflumilast (Zoryve; Arcutis) topical foam 0.3% for treating plaque psoriasis of the scalp and body in adults and adolescents 12 years and older. The once-daily, steroid-free foam formulation provides a new treatment option for the approximately 9 million Americans with plaque psoriasis, more than half of whom experience scalp involvement, according to an Arcutis statement.

An even greater proportion experience disease in other hair-bearing body areas, locations that aren't easily treated with standard creams or ointments, which can be both inconvenient and messy to apply. “Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging. A safe, effective foam offers a much-needed solution,” Jennifer Soung, MD, director of clinical research at Southern California Dermatology, and clinical trial investigator, said in the statement. "[Roflumilast] foam allows patients to treat their whole body with one prescription, transforming the treatment landscape for scalp and body psoriasis," Soung added.

Roflumilast foam, 0.3% is applied once daily and there are no limitations on application site or duration of use, according to Arcutis.

Clinical Trial Data

The FDA's approval of the next-generation topical phosphodiesterase-4 (PDE4) inhibitor was based on data from a phase 2 study and the pivotal phase 3 ARRECTOR clinical trial. The 2 trials combined enrolled 736 adults and adolescents aged 12 years and older with mild to severe plaque psoriasis of the scalp and body. All participants were randomly assigned to apply roflumilast foam, 0.3% or vehicle foam once daily for 8 weeks.

In the ARRECTOR study, two-thirds (66.4%) of participants treated with the study foam achieved Scalp-Investigator Global Assessment (S-IGA) Success compared to 27.8% with vehicle foam at week 8 (P <.001), satisfying the trial's primary endpoint. For Body-IGA Success at week 8, nearly half (45.5%) of roflumilast-treated participants vs fewer than one-quarter (20.1%) of participants treated with vehicle achieved success (P <.001).

Relief from itch, known to be the most burdensome symptom associated with plaque psoriasis and more common in those with scalp involvement, was also superior in roflumilast-treated vs vehicle-treated participants, with 65.3% of the former group achieving a clinically significant reduction in scalp itch versus 30.3% of those in the latter at week 8 (P <.001). Itch relief was quantified as a 4 point or greater reduction from baseline on the Scalp Itch-Numeric Rating Scale (SI-NRS). Notably, improvement in scalp itch was observed just 24 hours after the first application (P =.016).

Supporting data from the phase 2 trial (Trial 204) showed similar efficacy with 56.7% of participants treated with roflumilast achieving S-IGA Success vs just 11.0% reaching that level with vehicle. Body-IGA Success rates were 39.0% with roflumilast vs 7.4% with vehicle (P <.001 for both).

Treatment-emergent adverse events were low during both studies and generally similar between the active treatment and vehicle groups, a demonstration of treatment tolerability. The most common adverse reactions, occurring in at least 1% of participants included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). Discontinuation rates due to adverse events were low and similar between the 2 groups as well.

"Living with plaque psoriasis can have a profound impact on people's emotional well-being, quality of life, and social relationships. This can be even further exacerbated when psoriasis appears on the face, scalp, or thin-skinned areas," Leah Howard, president and chief executive officer of the National Psoriasis Foundation, said in the Arcutis statement. "We are pleased to see new advancements and innovation in treatments for the millions afflicted with this serious skin disease, that can be used long-term and anywhere the disease presents."

"With approval for [roflumilast] cream and now the foam formulation, individuals and clinicians can choose their preferred administration with powerful, long-term relief of plaques and itch anywhere on the body," Frank Watanabe, president and chief executive officer of Arcutis, added.

Psoriasis is a chronic inflammatory skin disease that causes scaling, erythema, and flaking. On darker skin tones, plaques may appear more grayish, purplish, or brown. Psoriasis can affect any area of the body and psoriasis of the scalp can extend to the forehead, back of the neck, or behind the ears and may contribute to hair loss due to excessive scratching or rubbing.

References

1. Arcutis’ ZORYVE® (roflumilast) topical foam 0.3% approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older. News release. Arcutis Biotherapeutics. May 22, 2025. Accessed May 22, 2025. https://www.arcutis.com/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-the-treatment-of-plaque-psoriasis-in-adults-and-adolescents-ages-12-and-older/.
2. Arcutis announces publication of positive data from ARRECTOR trial evaluating ZORYVE® (roflumilast) foam 0.3% in individuals with plaque psoriasis in Journal of American Medical Association Dermatology. News release. Arcutis Biotherapeutics. May 7, 2025. Accessed May 22, 2025. https://www.arcutis.com/arcutis-announces-publication-of-positive-data-from-arrector-trial-evaluating-zoryve-roflumilast-foam-0-3-in-individuals-with-psoriasis-in-journal-of-american-medical-association-dermatology/