FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis Down to Age 2

The FDA has approved Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA) for roflumilast cream 0.3% (Zoryve) for the topical treatment of plaque psoriasis in children down to age 2. The approval expands the existing indication for adults and children down to age 6, includes intertriginous areas, and removes restrictions on duration of use. The expanded approval is based on data from a pediatric pharmacokinetic and safety study.¹

Children under age 6 with plaque psoriasis have had few approved options suited for long-term use, according to Arcutis and the National Psoriasis Foundation. Topical steroids are frequently used off-label in this population but carry restrictions on sensitive areas and continuous use. Roflumilast cream 0.3% becomes the first once-daily, steroid-free topical treatment approved for plaque psoriasis down to age 2. According to Arcutis, this marks the seventh FDA approval for roflumilast in 4 years.¹

The sNDA approval is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study (ARQ-151-216; NCT04746911), an open-label trial evaluating roflumilast cream 0.3% in children ages 2 to 5 years with plaque psoriasis involving at least 2% body surface area. The study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy. Supportive long-term safety data came from an open-label extension study (ARQ-151-306/DERMIS-OLE; NCT04286607), which evaluated safety and tolerability in the same age group for up to 24 weeks of treatment.^1,3

According to Arcutis, results from both studies showed safety and efficacy profiles generally consistent with those observed in the DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) phase 3 trials in adolescents and adults.¹ The release does not specify numeric efficacy or safety rates for the 2-to-5 age cohort itself.

Lisa Swanson, MD, FAAD, a board-certified pediatric dermatologist and clinical trial investigator at Ada West Dermatology, said young children with plaque psoriasis face disease involvement on sensitive skin, including the face and skin folds.

"In clinical studies, Zoryve cream 0.3% demonstrated consistent safety and efficacy in improving the signs and symptoms of plaque psoriasis as seen in adults and adolescents, and was safe and well tolerated in children as young as age 2," Swanson said. "This approval provides physicians and caregivers a targeted topical therapy that can be used anywhere on the body for any duration of time."¹

Roflumilast Cream 0.3% Safety Profile and Dosing

Roflumilast is a topical formulation of a targeted phosphodiesterase type 4 (PDE4) inhibitor.² Inhibiting PDE4 decreases production of pro-inflammatory mediators, reducing skin inflammation.² The cream is approved for once-daily application anywhere on the body, including intertriginous areas, without restriction on treatment duration.¹

For plaque psoriasis, the most common adverse reactions reported in at least 1% of patients treated with roflumilast cream 0.3% were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).² Roflumilast is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).² Arcutis did not report new safety signals specific to the 2-to-5 age cohort beyond profiles consistent with adult and adolescent data.¹

"Psoriasis in kids is on the rise, yet our treatment strategies for kids in preschool have not changed in decades. We need more options to treat plaque psoriasis in pediatric patients and we need them to be steroid-free, so I am so excited to see Arcutis pursue studies and indications for our littlest psoriasis patients," Swanson told Dermatology Times at the time of the sNDA submission.

Topical steroids remain commonly used in pediatric plaque psoriasis but are not recommended for sensitive areas or long-term continuous use, according to Swanson. Roflumilast cream 0.3% gives clinicians a steroid-free option without those restrictions for the youngest patients with the condition.¹

Expert Insights

In a recent interview, Jennifer Soung, MD, a dermatologist and clinical researcher at Southern California Dermatology in Santa Ana, clinical faculty at the University of California, Los Angeles, and a roflumilast investigator, shared her thoughts on the significance of the approval for pediatric patients.

“I love [roflumilast] as a first-line treatment. I think it's so valuable to have a once-daily steroid-free treatment for young children, where patients and their families can feel confident in applying it anywhere on the skin. And there's no limit on duration. I also really love the formulation; it doesn't have any irritants, and even has moisturizing properties,” Soung told Dermatology Times.

References

1. FDA approves Arcutis' Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children as young as age 2. News release. Arcutis Biotherapeutics. June 29, 2026. Accessed June 29, 2026. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-03-treatment-0
2. Zoryve. Prescribing information. Arcutis Biotherapeutics. Updated 2023. Accessed June 29, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215985s002lbl.pdf
3. Arcutis submits supplemental new drug application to the FDA for Zoryve (roflumilast) cream 0.05% to expand indication for treatment of atopic dermatitis to infants down to 3 months. News release. Arcutis Biotherapeutics. April 27, 2026. Accessed June 29, 2026. https://www.arcutis.com/arcutis-submits-supplemental-new-drug-application-to-the-fda-for-zoryve-roflumilast-cream-0-05-to-expand-indication-for-treatment-of-atopic-dermatitis-to-infants-down-to-3-months/