Roflumilast Foam Showed Strong Results for Scalp and Body Psoriasis in Teens and Adults

The once-daily Zoryve (roflumilast) foam, 0.3%, safely and effectively improved scalp and body plaque psoriasis symptoms, including itch, in patients ages 12 and older, showing its potential as a single treatment option, according to a new study published today in JAMA Dermatology.

Plaque psoriasis is a chronic skin condition that causes discomfort, itch and emotional distress.

As of 2021, more than 7.5 million adults aged 20 or older have psoriasis. According to the National Psoriasis Foundation, every year, roughly 20,000 children under age 10 are diagnosed with psoriasis.

When the scalp is affected—something nearly half of patients experience—treatment becomes even more challenging, the study shared.

Plaque psoriasis found on the hairline of the scalp. Psoriasis is a chronic skin condition that causes discomfort, itch and emotional distress.

Hair can interfere with the application of creams and ointments, making some treatments messy, inconvenient or hard to stick with.

For patients who have psoriasis on the body and the scalp, managing multiple products with different textures can complicate daily routines and reduce adherence to treatment.

Roflumilast foam, 0.3%, can offer a promising alternative.

This topical option is designed to be easy to apply on both hair-bearing and non–hair-bearing areas, which may help improve patient adherence and outcomes.

Rather than older treatments, roflumilast does not contain alcohols or fragrances that can irritate the skin or damage hair.

The foam is a potent phosphodiesterase 4 (PDE4) inhibitor that targets the inflammation leading to psoriasis and also helps reduce itch, one of the more bothersome symptoms for patients.

In clinical trials, roflumilast foam has shown strong potential in reducing psoriasis symptoms on both the scalp and body.

Though, in this study, researchers explored roflumilast foam’s safety and effectiveness in teens and adults.

In a phase 3, double-blind, randomized clinical trial called the ARRECTOR trial, researchers tested the effectiveness of roflumilast foam, 0.3%, in over 400 participants ages 12 or older.

Roflumilast foam, 0.3%, was compared to a vehicle foam in treating plaque psoriasis.

Conducted at 49 sites in the U.S. and Canada between August 2021 and June 2022, participants involved had scalp and body psoriasis and met specific severity and body surface area criteria.

They were randomly assigned in a 2:1 ratio to receive either roflumilast foam or the vehicle foam, applied once daily for 8 weeks.

Authors shared the main goals were to measure improvement in scalp and body psoriasis severity and itch reduction.

Researchers also tracked safety, depression symptoms and adverse events.

At the end of the 8-week monitoring period, data revealed that more patients using roflumilast achieved clear or nearly clear skin compared to those using the vehicle option.

For example, 66.4% of patients in the roflumilast group reached success on the Scalp Investigator’s Global Assessment (S-IGA) compared to 27.8% in the vehicle group.

Improvements were observed as early as week 2 and continued through week 8 across other key measures, including the Body Investigator’s Global Assessment (B-IGA), a clinician-rated scale that defines success as achieving clear or almost clear skin on the body; the Psoriasis Area and Severity Index with 75% improvement (PASI-75), which reflects a significant reduction in overall psoriasis severity and body surface area affected and the Psoriasis Scalp Severity Index with 75% improvement (PSSI-75), which indicates a substantial improvement in scalp psoriasis severity.

Patients using roflumilast also reported greater relief from itch and discomfort, with differences seen in symptom improvement within 24 hours of treatment.

Patient-reported outcomes, including itching, pain and scaling, improved significantly more in the roflumilast group.

While adverse events were more frequent in the roflumilast group (26.7% vs 16.6%), most were mild or moderate, and serious events were rare and similar between groups.

Treatment tolerability, both patient- and investigator-rated, was high in both groups, with minimal local irritation.

There were also no signs of depression or suicidal thoughts linked to treatment.

The success of this study stems from its results displaying that the once-daily roflumilast foam, 0.3%, significantly improved both clinician- and patient-reported outcomes for those with psoriasis on the scalp and body.

Strengths of the study include early and continued improvements in symptoms such as pruritus, which can encourage better treatment adherence and strong alignment between clinical and patient-reported benefits.

The foam’s design also offers advantages, including making it easier to use on both hair-bearing and non–hair-bearing areas, which could improve patient satisfaction and quality of life.

In addition, the results are consistent with previous trials using roflumilast cream.

However, the study included some limitations.

For example, few participants were under 18, which limits data about pediatric use, and the eight-week duration does not provide insight into long-term efficacy or safety.

Authors shared that it’s also still unclear how roflumilast foam performs relative to other treatments.

The authors suggest that future research should explore long-term effects and compare the foam with other therapies to better understand its role in psoriasis treatment.