In a post hoc assessment of pooled data from two phase III studies, treatment with 2% crisaborole ointment led to improvement in global disease severity and showed good tolerability across all pediatric baseline characteristic subgroups with no novel safety concerns. Researchers investigated safety and effectiveness of crisaborole ointment to treat atopic dermatitis in pediatrics only, stratified by baseline characteristics.

Pediatrics with atopic dermatitis (aged 2 to <18 years) having a baseline Investigator’s Static Global Assessment (ISGA) of mild or moderate and baseline % body surface area of ≥ 5 were evaluated. Vehicle or crisaborole was applied twice daily for twenty-eight days. Of 1313 pediatrics incorporated, 439 were given vehicle and 874 were given crisaborole. The ISGA success was described as almost clear (1) or clear (0) with ≥ 2-grade improvement from the baseline.

Effectiveness and safety were stratified by baseline ISGA, gender, age group, baseline % body surface area per published severity strata, and previous atopic dermatitis treatment. The rates of treatment-linked application site pain, and the percentage of  vehicle-treated and crisaborole-treated pediatrics with ISGA success at the fourth week are shown in Table 1. The ISGA success rates at day 29 (fourth week) were usually greater in crisaborole group when compared to vehicle-treated participants across subgroups.

There were no novel safety concerns reported. Application site discomfort was higher with crisaborole when compared to the vehicle. However, only a few volunteers discontinued treatment. Hence, the nonsteroidal phosphodiesterase 4 inhibitor crisaborole was effective and well-tolerated in atopic dermatitis children aged 2 to < 18 years.