Roflumilast Foam 0.3% for Scalp, Body Psoriasis Effective, Safe for Patients

Positive phase 3 findings on the safety and efficacy of roflumilast foam 0.3% (Zoryve) for those with psoriasis of the scalp and body as a once-daily monotherapy have been published in the Journal of the American Medical Association (JAMA) Dermatology, with results demonstrating rapid and significant relief following treatment.1,2

These data were released on May 7, and they were the conclusion of the phase 3 ARRECTOR study, authored by such investigators as Melinda Gooderham, MD, MSc, medical director at the SKiN Centre for Dermatology. Gooderham and the coauthors noted that prior to their research, topical therapeutic options for scalp psoriasis had been limited by efficacy, by formulation, and/or by safety.2

“Plaque psoriasis is a chronic and burdensome disease that often leaves people searching for relief from thick scales, itch, and discomfort – especially when it affects the scalp, where treatment can be particularly challenging,” Gooderham said in a statement.1 “These compelling results demonstrate that [roflumilast] foam 0.3% may provide rapid and significant relief of plaques anywhere on the body and is well-tolerated according to both investigator and patient-reported assessments."

The investigators' phase 3 study involved a randomized, vehicle-controlled, double-blind, clinical trial design. The research, conducted across 49 sites within Canada and the US, took place in the timeframe between August 2021 - June 2022.

Those involved as participants were given once-per-day roflumilast foam 0.3% or a matching vehicle for a total of 8 weeks. The study's coprimary endpoints were success on the Scalp Investigator Global Assessment (S-IGA) and Body Investigator Global Assessment (B-IGA), which Gooderham et al defined as attaining a rating of clear (0) or almost clear (1) as well as at least a 2-grade improvement by the 8-week mark.

In their evaluation of secondary outcomes, the investigative team included S-IGA success at the 2 and 4-week marks, shifts in subjects' Scalp Itch Numeric Rating Scale (SI-NRS) scores, and attainment of a ≥4-point SI-NRS and Worst Itch NRS (WI-NRS) score reduction among those showing baseline scores of 4 or higher. Safety and tolerability were also evaluated by the team.

Those included as participants were required to be aged 12 years and older and to have plaque psoriasis involving up to 25% of their total body surface area. They were also required to have at least 10% scalp psoriasis involvement and up to 20% involvement on their non-scalp areas.

The subjects would also be required to have a minimum S-IGA score of 3 and a minimum B-IGA score of 2. The aforementioned outcomes were evaluated by Gooderham and colleagues between September - December 2022. There were 432 individuals randomized in the analysis, with 281 to the roflumilast arm and 151 to the vehicle arm.

Participants' average age was shown by the investigators to be 47.3 years (SD, 14.8). They also highlighted that 56.3% of subjects had been identified as women.

Overall, the 8-week findings demonstrated that 66.4% of subjects in the roflumilast arm were able to achieve S-IGA success versus only 27.8% of those in the vehicle arm (P < .001). The investigators further highlighted that 45.5% of the roflumilast cohort achieved B-IGA success versus only 20.1% in the vehicle cohort (P < .001).

“The foam formulation is particularly beneficial for its versatility in treating hair-bearing and non-hair-bearing skin, which could ultimately help patients adhere to their treatment,” Gooderham said in a statement.1

Roflumilast foam was shown by the team to have outperformed the vehicle on a variety of secondary endpoints, with notably higher rates of S-IGA success at the 2-week mark and greater proportions of participants reporting successes in SI-NRS and WI-NRS scores at the 2, 4, and 8-week marks.

SI-NRS improvements were also observed by Gooderham and coauthors as early as 24 hours following the topical's first application among those in the roflumilast group. Both of the treatment cohorts demonstrated low adverse event rates and were shown to be generally well-tolerated.

“These data demonstrate that investigational [roflumilast] foam rapidly relieved psoriasis symptoms, including the most troublesome symptom of itch,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in a statement.1 “As an effective, safe, and well-tolerated once-daily treatment, [roflumilast] foam 0.3%, if approved, will offer those living with psoriasis a potential new treatment option for use anywhere on the body with no limitations on duration of use.”

Burnett highlighted that the company looks forward to a potential approval by the US Food and Drug Administration (FDA) of roflumilast foam 0.3% for plaque psoriasis of the scalp and body. A decision by the FDA, he noted, is anticipated by late May.1

References

1. 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. Arcutis Biotherapeutics. May 7, 2025. https://www.globenewswire.com/news-release/2025/05/07/3076357/0/en/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-D.html.

2. Gooderham MJ, Alonso-Llamazares J, Bagel J, et al. Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. JAMA Dermatol. Published online May 07, 2025. doi:10.1001/jamadermatol.2025.1136.