FDA Approves Foam to Treat Scalp Eczema in Children and Adults

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The U.S. Food and Drug Administration (FDA) has approved the topical foam Zoryve (roflumilast) to treat an inflammatory skin condition known as seborrheic dermatitis, commonly called scalp eczema, that can cause a scaly, itchy rash on the scalp and skin.

Zoryve foam is cleared to treat seborrheic dermatitis in adults and children 9 years and older and will be available in the United States by the end of January, its developer, Arcutis Biotherapeutics, said in a statement.

“There has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” said Patrick Burnett, MD, PhD, the chief medical officer at Arcutis, in the statement. “Zoryve foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use.”

Seborrheic dermatitis is a chronic type of eczema that typically appears on the scalp and other areas of the skin where there are lots of oil-producing sebaceous glands. It causes an itchy rash on the head known as cradle cap in babies. In adults, milder cases of seborrheic dermatitis can cause dandruff. More severe cases can lead to thickened skin patches, and persistent scratching can also cause serious skin infections.

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