Zoryve: FDA Expands Use of Once-Daily Steroid-Free Skin Cream for Children Ages 2-5 Years With Mild to Moderate Eczema

Zoryve (roflumilast) cream is a prescription steroid-free medicine for treating inflammatory skin conditions such as atopic dermatitis (eczema) and plaque psoriasis. Zoryve works by blocking an enzyme called PDE4 (phosphodiesterase 4). This in turn helps calm skin inflammation and reduce redness, itching, and swelling.

The FDA has now approved a lower-strength (0.05%) version of this cream for children with mild to moderate eczema ages 2-5 years. Affecting up to 20% of children worldwide, eczema is a long-term skin condition that causes dry, itchy, and inflamed skin that can cover large areas of the body. Itching is one of the most uncomfortable symptoms of eczema, and children often get trapped in a relentless itch-scratch cycle that can worsen their condition and cause sleep disturbances, skin infections, and emotional stress for both them and their families. In the U.S., about 1.8 million children ages 2-5 years use creams or ointments to manage eczema.

This approval matters because Zoryve cream 0.05% provides a steroid-free treatment that’s safe to use once a day on any part of the body for a long duration and doesn’t harm the skin’s natural barrier. Unlike topical steroids, which can cause irritation and are recommended for short-term use, Zoryve offers a long-term alternative that may help young children manage eczema symptoms, provide comfort, and improve quality of life.

Why Was It Approved?

Zoryve was approved after clinical studies showed that it was safe and well tolerated, provided quick relief, and helped improve symptoms in children 2-5 years old with mild to moderate eczema.

In a study involving 652 children ages 2-5 years, 25.4% of those using Zoryve cream 0.05% once daily, versus 10.7% of children using a placebo, showed improvement in skin clearing by week four. Also, at week four, nearly 40% of children using the cream, versus 20% of those on a placebo, saw a 75% reduction in their eczema symptoms, and over one-third of those using the cream had significant relief from itching – often within 24 hours of the first use. The treatment was well tolerated, with very few children having mild or moderate side effects.

The most common side effects were mild and included upper respiratory tract infections, diarrhea, vomiting, a runny nose, pink eye, and a headache.

What Do I Need to Know?

Zoryve cream 0.05% is water-based and does not contain alcohol, propylene glycol, or added fragrances – ingredients that can irritate sensitive skin. It is used once a day on areas of skin affected by eczema, including sensitive spots, for as long as needed. Wash your hands before and after applying the cream. Rub it gently over the affected areas of your child’s skin until you no longer see it. It’s meant to be used only on the skin and should not be applied to your child’s eyes, mouth, or private areas.

Zoryve should not be used if your child has moderate to severe liver problems. Be sure to tell your doctor about all medicines, including over-the-counter products, herbal remedies, and vitamin supplements, your child takes, especially ones that affect how the liver processes drugs. These medicines may increase the chance of side effects.

Zoryve is expected to be available in the U.S. by the end of October. It is not a cure for eczema, but it may help manage symptoms as long as needed.