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FDA Approves Zoryve Foam To Treat Seborrheic Dermatitis

Posted on January 12, 2024

On Dec. 15, 2023, Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) approved roflumilast (Zoryve) foam for the treatment of seborrheic dermatitis in adults and in children over 9 years old.

Zoryve topical foam, 0.3 percent, is a once-daily, steroid-free treatment for use on all parts of the body affected by seborrheic dermatitis, including areas with hair.

What Makes Zoryve Foam Different?

Zoryve foam is the first approved seborrheic dermatitis drug with a new mechanism of action in over 20 years. This topical foam is a phosphodiesterase 4 inhibitor, and it works on the immune system to help decrease inflammation. Previous seborrheic dermatitis treatment options were limited to topical corticosteroids and antifungals.

What Did the Clinical Trials Find?

According to the results of the Stratum phase 3 study, after eight weeks, 80 percent of people using Zoryve foam achieved clear or almost clear skin and an improvement in symptoms like itch, with 50 percent showing complete clearance or resolution of seborrheic dermatitis skin symptoms. Some participants reported statistically significant improvement by week two of using Zoryve.

People who used Zoryve also experienced a greater reduction in symptoms like itch, redness, and scaling compared with those who didn’t use this treatment. After eight weeks, over 60 percent of people using Zoryve had at least a four-point reduction in itch severity — based on a scale from zero to 10 — and 28 percent felt improvement within two days.

Results of the clinical trial showed Zoryve to be safe and well tolerated by people who used it.

When Will Zoryve Foam Be Available?

According to the manufacturer, Zoryve foam should be available to key wholesalers and dermatology pharmacy channels by the end of January. If you have questions about the drug and are curious if you’d be a good candidate for it, ask your dermatologist.

Talk With Others Who Understand

MySebDermTeam is the social network for people with seborrheic dermatitis and their loved ones. Here, more than 7,000 members come together to ask questions, give advice, and share their stories with others who understand.

Are you interested in trying Zoryve? Have you talked with your doctor about new medications? Share your tips and experiences in a comment below or on your Activities page.

Posted on January 12, 2024

A MySebDermTeam Member

I have an appt with my Dermatologist tomorrow & will ask about this. Does it make you sun sensitive for scalp?

posted April 21
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January 21, 2024 by A MySebDermTeam Member 3 answers
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Elizabeth Wartella, M.P.H. is an Associate Editor at MyHealthTeam. She holds a Master's in Public Health from Columbia University and is passionate about spreading accurate, evidence-based health information. Learn more about her here.

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