In recent phase 3 clinical trials, nearly 1 in 3 people with mild to moderate atopic dermatitis (a type of eczema) achieved clear or nearly clear skin from applying roflumilast cream, 0.15 percent. Sold under the brand name Zoryve, this cream works by targeting and inhibiting phosphodiesterase 4 (PDE4), an enzyme (protein) that drives inflammation in the skin. Like some other topicals for atopic dermatitis, roflumilast contains no steroids, which can cause unwanted side effects such as skin thinning and discoloration. It also differs from similar treatments in that it’s indicated to be applied just once a day instead of twice.
The clinical trials evaluated 1,337 individuals with mild to moderate atopic dermatitis. At week four, close to 30 percent of those using roflumilast cream achieved clear or nearly clear skin, compared to roughly 13 percent of those using a vehicle cream that didn’t contain the treatment. Roflumilast cream also significantly reduced eczema severity, with around 43 percent of participants achieving a 75 percent improvement in their Eczema Area and Severity Index scores, compared with about 20 percent of people who used the vehicle cream. Roflumilast also eased itching within 24 hours of application.
Roflumilast was well tolerated, with users reporting no irritation and only mild sensation, if any, at the application site.
Treatments for atopic dermatitis include corticosteroids, immunosuppressants, systemic medications, and phototherapy. All work in different ways to help reduce inflammation, relieve itching, and improve the skin’s barrier. Roflumilast cream was approved by the U.S. Food and Drug Administration (FDA) for atopic dermatitis in 2024.
Roflumilast is one of several steroid-free topical treatments for mild to moderate atopic dermatitis, including PDE4 inhibitors like crisaborole (Eucrisa) and calcineurin inhibitors such as tacrolimus (Protopic). The absence of steroids may appeal to individuals who wish to avoid topical steroids or treatments with potentially more severe side effects. This benefit, along with once-daily application, may help people stick to their treatment plans more easily.
Because every individual responds differently to treatments, it’s important to work with your dermatologist to find the option that best meets your needs and goals.
Learn more about the treatments for atopic dermatitis and other forms of eczema.
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