Crisaborole ointment well tolerated in children younger than 2 years

In a phase 4 study, young patients with mild to moderate eczema aged 3 months to younger than 24 months tolerated treatment with crisaborole ointment 2%, which is consistent with previous clinical trials, according to Pfizer.

Crisaborole ointment 2% is a novel, steroid-free topical phosphodiesterase inhibitor from Pfizer that is approved in the U.S. and Canada as Eucrisa and Israel and Australia as Staquis for mild to moderate atopic dermatitis for patients aged 2 years and older, according to a press release from Pfizer.

The multicenter, open-label, single-arm study (CrisADe Care 1) evaluated the pharmacokinetics and efficacy of crisaborole ointment 2% applied twice daily for 4 weeks in 125 pediatric patients aged 3 months to younger than 24 months with mild to moderate atopic dermatitis of at least 5% treatable body surface area, excluding the scalp.

The study also included a cohort of 16 patients with clinical diagnoses of moderate atopic dermatitis and a minimum of 35% treatable body surface area, excluding the scalp.

Primary endpoints included the number of patients with treatment-emergent adverse and severe events, clinically significant changes from baseline in height, weight, vital signs, ECG and clinical laboratory parameters.

Pfizer plans to present additional data at a scientific meeting later this year or early in 2020, according to a media spokesperson.