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Topical corticosteroids are the mainstay of treatment for patients with atopic dermatitis, but they can cause skin atrophy and discoloration, and many patients have incomplete responses to them. Alternatives include topical calcineurin inhibitors (i.e., tacrolimus and pimecrolimus), the topical JAK inhibitor ruxolitinib, and the topical phosphodiesterase-4 (PDE-4) inhibitor crisaborole. Topical roflumilast is a potent PDE-4 inhibitor that was U.S. FDA approved recently for managing mild-to-moderate atopic dermatitis in patients 6 years or older.
In the two trials that led to FDA approval, 1337 patients (age, ≥6 years) were randomized to roflumilast (0.15% cream) or placebo once daily. After 4 weeks, significantly more patients in the active-…