On May 22, 2025, the FDA approved roflumilast (Zoryve; Arcutis Biotherapeutics) topical foam 0.3% to treat plaque psoriasis of the scalp and body in patients aged 12 years and older, according to a press release from Arcutis.¹

According to the company, nearly 9 million people in the United States live with plaque psoriasis, and over half have scalp involvement. Even more patients present with the disease in other hair-bearing areas. Lesions can prove difficult to treat with creams or ointments, which can be inconvenient to apply to skin where hair is present. In clinical trials, roflumilast foam 0.3% demonstrated clinically significant improvements in signs and symptoms of psoriasis on the body and scalp while also demonstrating safety and tolerability.

"Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging," said Jennifer Soung, MD, director of clinical research at Southern California Dermatology and clinical trial investigator, in a statement. "In clinical trials, [roflumilast] foam not only effectively cleared psoriasis plaques on the body and scalp, but also provided rapid itch relief. [Roflumilast] can be safely used for any duration and offers two highly convenient formulations, cream or foam, for healthcare providers to choose from," added Soung. "[Roflumilast] foam allows patients to treat their whole body with one prescription, transforming the treatment landscape for scalp and body psoriasis."

WATCH: Contemporary Pediatrics spoke with Soung to further highlight the importance and impact of the FDA decision. Click here to watch this video interview.

Trial data that led to approval

The FDA's decision to approve roflumilast foam 0.3% was based on the phase 2 and phase 3 trials, including the phase 3 ARRECTOR study and phase 2 Trial 204. These studies were multicenter, randomized, double-blind, vehicle-controlled studies evaluating the safety and efficacy of ZORYVE foam 0.3% in plaque psoriasis. Together, the 2 studies enrolled 736 adults and adolescents aged 12 years and older with mild to severe plaque psoriasis of scalp and body. In each trial, subjects were randomized 2:1 to receive ZORYVE foam 0.3% or vehicle foam applied once daily for 8 weeks.

Results among participants in the ARRECTOR study (n = 432) demonstrated that the topical treatment met the primary endpoints. Overall, 66.4% of individuals treated with roflumilast foam 0.3% achieved a Scalp-Investigator Global Assessment (S-IGA) Success. S-IGA success was defined as an IGA score of clear or almost clear, plus a 2-point improvement from baseline, compared to 27.8% of individuals treated with a matching vehicle at week 8 (P < 0.0001).^1,2

Additionally, as previously reported by Contemporary Pediatrics, 45.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success compared to 20.1% of individuals treated with a matching vehicle foam at Week 8 (P < 0.0001).²

In Trial 204, the primary endpoint was also met, as 56.7% of individuals treated with roflumilast foam 0.3% achieved S-IGA success compared to 11% of those treated with a matching vehicle foam at week 8 (P < 0.0001). B-IGA success was demonstrated in 39% of roflumilast-treated individuals compared to 7.4% of participants who received vehicle at week 8 (P < 0.0001).¹

Roflumilast foam 0.3% improvements in itch

Regarding itch, the most burdensome symptom of psoriasis that can occur anywhere on the body, the foam led to a clinically meaningful improvement. In the ARRECTOR trial, 65.3% of patients treated with roflumilast achieved a clinically significant reduction in itch vs those treated with vehicle by week 8 (P < 0.0001). The reduction was measured by a ≥4-point change from baseline in the Scalp Itch-Numeric Rating Scale (SI-NRS), stated Arcutis.

In scalp itch, a larger improvement was observed 24 hours after the first application of roflumilast foam 0.3% compared to vehicle (P = 0.0164), which was consistent with Trial 204, as a higher percentage of individuals achieved SI-NRS vs vehicle at week 8 (67.3% vs 20.7%).

Body itch, measured by the Worst Itch-Numeric Rating Scale (WI-NRS), was improved with roflumilast, as 63.1% treated with the foam achieved WI-RNS success (a ≥ 4-point reduction in WI-NRS) compared to 30.1% of those treated with vehicle in the ARRECTOR trial (P < 0.0001).

Tolerability of roflumilast foam 0.3%

Overall, roflumilast was well tolerated, with the incidence of treatment-emergent adverse events low and generally observed to be similar to vehicle. Most of these events were assessed as mild to moderate severity. Overall, the most common adverse reactions for ZORYVE foam for plaque psoriasis in the Phase 3 and Phase 2 studies combined (≥1%) included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

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

Approved indications for roflumilast

With the FDA's decision, roflumilast is now approved for the following indications (click each link for more information on each indication):

• To treat plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older
• Roflumilast foam 0.3% to treat seborrheic dermatitis in adult and pediatric patients aged 9 years and older
• Roflumilast cream 0.3% to treat plaque psoriasis in adult and pediatric patients aged 6 years and older
• Roflumilast cream 0.15% to treat mild-to-moderate atopic dermatitis in adult and pediatric patients aged 6 years and older

Editor's note: This is the first part of a series highlighting the FDA approval of roflumilast foam 0.3%.

Click here for part 2, a reaction video interview with Jennifer Soung, MD.

Click here for part 3, which includes additional commentary from health care professionals.

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. Arcutis Biotherapeutics, Inc. Press release. May 22, 2025. Accessed May 22, 2025.

2. Fitch, J. FDA accepts roflumilast's sNDA to treat scalp and body psoriasis in adolescents, adults. Contemporary Pediatrics. September 24, 202. Accessed May 22, 2025. https://www.contemporarypediatrics.com/view/fda-accepts-roflumilast-s-snda-scalp-and-body-psoriasis-in-adolescents-adults