For a study, it was determined that crisaborole 2% ointment was a nonsteroidal phosphodiesterase 4 inhibitor used to treat mild to severe atopic dermatitis (AD). For an open-label trial, researchers wanted to assess the safety, efficacy, and pharmacokinetics (PK) of crisaborole in babies aged 3 to less than 24 months with mild-to-moderate AD. Crisaborole was given twice daily for 28 days to infants (3 to < 24 months) with mild or moderate Investigator’s Static Global Assessment (ISGA) and a percentage of treatable body surface area (% BSA) greater or equal to 5; a cohort with moderate AD per ISGA and %BSA of greater or equal to 35 was included in a PK analysis. The key endpoints were safety, effectiveness, and PK (exploratory).
A total of 137 babies (mean age [SD], 13.6 months [6.42]) were included in the study, including 21 in the PK cohort (12.7 months [6.58]). Treatment-emergent adverse events (TEAEs) were reported by 88 (64.2%) of the patients (98.9% were mild/moderate). TEAEs that were Treatment-related were recorded by 22 patients (16.1%), with application site pain (3.6%), application site discomfort (2.9%), and erythema being the most common (2.9%). About 30.2% of patients obtained ISGA clear/almost clear with a 2-grade improvement at day 29. The mean percentage change in Eczema Area and Severity Index score was -57.5% from baseline to day 29, while the mean change in Patient-Oriented Eczema Measure total score was -8.5. Crisaborole systemic exposures in babies were studied and shown to be equivalent to that in patients under the age of two years, according to nonlinear regression analysis.
Crisaborole was well tolerated and efficacious in babies (3 to < 24 months) with mild-to-moderate AD in this open-label research, with systemic exposures comparable to patients aged more than or equal to 2 years.