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FDA Approves Eucrisa for Eczema

FDA news release; 2016 Dec 14

The FDA has approved Eucrisa (crisaborole) ointment (Pfizer, Inc.) to treat mild to moderate eczema (atopic dermatitis) in patients aged 2 years and older.

Indication: Eucrisa is indicated for topical treatment of mild to moderate atopic dermatitis in patients aged 2 years and older.

Dosage and administration: Eucrisa, applied topically twice daily, is a phosphodiesterase 4 (PDE-4) inhibitor, although its specific mechanism of action in atopic dermatitis is not known.

Safety and efficacy: The safety and efficacy of Eucrisa were established in 2 placebo-controlled trials with a total of 1,522 participants ranging in age from 2 years to 79 years, with mild to moderate atopic dermatitis. Overall, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment.

Adverse reactions: Serious side effects of Eucrisa include hypersensitivity reactions. Eucrisa should not be used in patients who have had a hypersensitivity reaction to Eucrisa’s active ingredient, crisaborole. The most common side effect of Eucrisa is application site pain, including burning or stinging.


US Food and Drug Administration. FDA approves Eucrisa for eczema. FDA web site. December 14, 2016. Accessed December 16, 2016.