Roflumilast Foam 0.3% Significantly Reduces Pruritus and Improves Quality of Life in Scalp and Body Psoriasis
More than half (55.4%) of roflumilast-treated patients achieved a score of 0 or 1 vs 19.8% in the vehicle group on the Worst Itch-NRS numeric rating scale.
In 2 abstracts released at the 2025 American Academy of Dermatology Meeting today, Arcutis Biotherapeutics presented data from phase 3 clinical trials for atopic dermatitis and scalp and body psoriasis. The meeting is being held from March 7-11, in Orlando, FL.
In findings from the phase 3 ARRECTOR trial, individuals aged 12 years and older with scalp and body psoriasis treated with once-daily roflumilast foam 0.3% experienced significant improvements in pruritus and quality of life compared to those receiving vehicle. At week 8, more than half of participants treated with roflumilast achieved a near-complete resolution of itch, with 52.3% reaching a score of 0 or 1 on the Scalp Itch-Numeric Rating Scale (SI-NRS) vs 24.1% in the vehicle group (P <.001). Similar improvements were seen on the Worst Itch-NRS (WI-NRS), with more than half (55.4%) of roflumilast-treated patients achieving a score of 0 or 1 compared to 19.8% in the vehicle group (P <.001).
Scalp or body psoriasis has a significant negative impact on quality of life, with individuals reporting pruritus as the most burdensome symptom. Roflumilast foam 0.3% is a once-daily, novel, highly potent phosphodiesterase 4 inhibitor under investigation for treatment the disorder.
The ARRECTOR trial enrolled 432 participants with scalp psoriasis of at least moderate severity (Scalp-Investigator Global Assessment [S-IGA]) and mild body psoriasis (Body-IGA), affecting 25% or more of total body surface area. Participants were randomly assigned 2:1 for treatment with roflumilast foam 0.3% (n=281) or vehicle (n=151) for 8 weeks.
Patient-reported outcomes demonstrated consistent improvements across multiple domains. The Psoriasis Symptom Diary assessed in adults, showed significant reductions in both severity and bothersomeness of psoriasis symptoms, particularly pruritus. Emotional burden, including embarrassment, was also significantly reduced. Additionally, patients treated with roflumilast reported significantly greater reductions in Scalpdex total scores at Week 8 compared to the vehicle group, reflecting overall improvements in quality of life.
Safety outcomes were similar to those reported in previous trials of roflumilast cream 0.3% in individuals with psoriasis. The majority of treatment-emergent adverse events (TEAEs) were mild or moderate in both the roflumilast (96.0%) and vehicle (92.0%) groups. Just 5.7% and 2.0% of the of TEAEs were considered related to study treatment, respectively. Discontinuations of the study due to TEAEs similar between the roflumilast (n=5 [1.8%]) and vehicle (n=2 [1.3%]) groups and were described as “limited.”
For data on the atopic dermatitis findings, please click here.
