Last week, the FDA approved Arcutis Biotherapeutics' roflumilast foam 0.3% to treat plaque psoriasis of the scalp and body in patients aged 12 years and older, adding a nonsteroidal, once-daily, phosphodiesterase-4 inhibitor to the provider toolkit.^1,2

The approval has been well-received in the dermatology field, with experts praising the product's safety and efficacy. Below is a brief data recap, along with quick reactions from health care professionals regarding the approval, and what it means for the pediatric population.

Click through the slideshow below for reactionary comments from clinical trial investigator Jennifer Soung, MD, Bernard Cohen, MD, and Donna Hallas, PPCNP-BC, CPNP, PMHS, FAANP, FAAN.

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. 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

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).

Click here for full approval details.

Reaction to the approval of roflumilast foam 0.3%

In a video interview with Contemporary Pediatrics, Jennifer Soung, MD, further explained the benefits of roflumilast foam 0.3% can provide to those with scalp and body psoriasis and how this approval can change the landscape for treatment. Watch the ad-free video at the link below.

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

Click here for part 1, which includes full approval details.

Click here for part 2, which is an extended interview with Jennifer Soung, MD.

References:

1. Fitch, J. FDA approves roflumilast foam 0.3% for scalp, body psoriasis. Contemporary Pediatrics. May 22, 2025. Accessed May 28, 2025. https://www.contemporarypediatrics.com/view/fda-approves-roflumilast-foam-0-3-for-scalp-body-psoriasis

2. FDA Accepts Arcutis’ Supplemental New Drug Application for ZORYVE (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over. September 24, 2024. Accessed May 28, 2025. https://www.arcutis.com/fda-accepts-arcutis-supplemental-new-drug-application-for-zoryve-roflumilast-foam-for-the-treatment-of-scalp-and-body-psoriasis-in-adults-and-adolescents-ages-12-and-over/