ARRECTOR: Roflumilast Foam 0.3% Shows Strong Efficacy for Scalp and Body Psoriasis

A once-daily roflumilast foam formulation significantly improved scalp and body psoriasis in a pivotal phase 3 trial, according to a press release from Arcutis Biotherapeutics, Inc.

Researchers for the randomized, double-blind, vehicle-controlled ARRECTOR study enrolled 432 adolescents and adults aged 12 years and older with plaque psoriasis on the scalp and body. Participants received once-daily treatment with ZORYVE® (roflumilast) foam 0.3% or vehicle over an eight-week period across 49 sites in the U.S. and Canada.

According to the data, at week 8, 66.4% of patients treated with ZORYVE foam achieved Scalp-Investigator Global Assessment (S-IGA) success—defined as an IGA score of "clear" or "almost clear" with at least a two-grade improvement) vs. 27.8% with vehicle (P < .0001). Nearly half (45.5%) achieved Body-IGA success vs. 20.1% in the control arm (P < .0001).

Pruritus improvements were seen as early as 24 hours after application. By week 8, 65.3% of patients achieved ≥4-point reduction in scalp itch (SI-NRS) and 63.1% experienced the same degree of body itch improvement (WI-NRS). Both outperformed vehicle (P < .0001).

Key secondary endpoints were also met. Psoriasis Scalp Severity Index (PSSI-75) was achieved in 70.9% of treated patients vs. 31.3% assigned vehicle, and Psoriasis Area and Severity Index (PASI-75) was achieved in 50.1% of the treatment group vs. 16.8% of those on vehicle (P < .001). The foam was well tolerated and only a low incidence of treatment-emergent adverse events (TEAEs) was observed.

“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,” said Melinda Gooderham, MD, MSc, FRCPC, the study’s lead author and dermatologist at SKiN Centre for Dermatology.

A supplemental New Drug Application (sNDA) for ZORYVE foam 0.3% remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) action date set for May 22, 2025.

“We are thrilled that JAMA Dermatology has published the positive results of our pivotal ARRECTOR study,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis, in the news release. “If approved, ZORYVE foam could offer a new, well-tolerated treatment option for people living with plaque psoriasis anywhere on the body.”

Source: Arcutis press release. May 7, 2025.