FDA Expands Roflumilast Cream 0.3% Approval for Plaque Psoriasis in Children Aged 2 Years and Older

The US Food and Drug Administration has approved a supplemental New Drug Application expanding the indication for roflumilast cream 0.3% (Zoryve; Arcutis) for the topical treatment of plaque psoriasis, including intertriginous areas, in children aged 2 years and older.

The approval makes roflumilast cream 0.3% the first once-daily, steroid-free topical therapy approved for children with plaque psoriasis as young as age 2, according to Arcutis. The topical phosphodiesterase-4 inhibitor was previously approved for plaque psoriasis in adults and children aged 6 years and older.

Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease that may begin early in life and persist for decades. In children, treatment can be complicated by involvement of sensitive areas, including the face, genitals, and intertriginous areas, where prolonged use of topical corticosteroids may be limited.

“Young children with plaque psoriasis face unique challenges, including disease involvement on sensitive skin, such as the face and skin folds,” Lisa Swanson, MD, FAAD, board-certified pediatric dermatologist and clinical trial investigator at Ada West Dermatology, said in the announcement. “Although topical steroids are commonly used to treat pediatric plaque psoriasis, they are not recommended on sensitive areas or for long-term, continuous use.”

The expanded indication was supported by data from a 4-week Maximal Usage Systemic Exposure study, ARQ-151-216, evaluating roflumilast cream 0.3% in children aged 2 to 5 years with plaque psoriasis involving at least 2% body surface area. The open-label study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy.

Supportive long-term safety data came from an open-label extension study, ARQ-151-306, which evaluated roflumilast cream 0.3% in patients aged 2 to 5 years with plaque psoriasis for up to 24 weeks. According to Arcutis, results showed safety and efficacy profiles generally consistent with those observed in the DERMIS-1 and DERMIS-2 pivotal phase 3 trials in adolescents and adults.

Roflumilast is a targeted topical PDE4 inhibitor. Inhibition of PDE4 decreases production of proinflammatory mediators and helps reduce inflammation in the skin.

Zoryve cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients aged 2 years and older. The product is for topical use only and is not for ophthalmic, oral, or intravaginal use.

Zoryve is contraindicated in patients with moderate to severe liver impairment, defined as Child-Pugh B or C. The most common adverse reactions reported in at least 1% of patients using Zoryve cream 0.3% for plaque psoriasis were diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection.

Reference

1. Arcutis Biotherapeutics. FDA approves Arcutis’ Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children as young as age 2. Published June 29, 2026.