Dermatologists and pediatric clinicians treating plaque psoriasis can now prescribe ZORYVE cream, 0.3%, once daily for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older per the revised FDA labeling ^[1][2]. The DERMIS-1 and DERMIS-2 randomized trials reported IGA treatment success rates of 41.5% vs 5.8% and 36.7% vs 7.1% (ZORYVE vs vehicle) at Week 8, supporting efficacy of once-daily 0.3% cream in the studied populations ^[3]. How roflumilast cream will be positioned relative to other topical or systemic options in children 2 to 5 years of age requires further clinical experience and comparative data?

Q1 What is ZORYVE (roflumilast) cream, 0.3%, approved for?

ZORYVE cream, 0.3%, is approved for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older. This approval follows supplemental FDA review and labeling updates that expand the indicated pediatric age range to include children 2 years and older. The approval and labeling are documented in FDA correspondence and the revised prescribing information.

Q2 How does roflumilast (ZORYVE) work?

Roflumilast is a phosphodiesterase-4 (PDE4) inhibitor. Inhibition of PDE4 and its active metabolite’s activity leads to accumulation of intracellular cyclic AMP; the specific mechanism(s) by which roflumilast exerts its therapeutic action in plaque psoriasis are not well defined in the prescribing information. The drug and its N-oxide metabolite are described in the clinical pharmacology sections of the label.

Q3 What is the recommended dose of ZORYVE cream, 0.3% for plaque psoriasis?

For plaque psoriasis, the approved regimen for ZORYVE cream, 0.3%, is to apply the cream once daily to affected areas and rub in completely. The full prescribing information includes administration instructions and cautions regarding topical use only and avoidance of ophthalmic, oral, or intravaginal use. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects of ZORYVE cream, 0.3% in plaque psoriasis?

The most common adverse reactions reported in subjects with plaque psoriasis treated with ZORYVE cream, 0.3%, were diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection. The label describes adverse reaction frequencies observed in the controlled trials and long-term extension data, and clinicians are directed to the full prescribing information for detailed safety and monitoring information.

Clinicians should consult current prescribing information for complete dosing guidance.