Crisaborole 2% ointment is a nonsteroidal phosphodiesterase 4 inhibitor used to treat mild-to-moderate atopic dermatitis (AD). The goal of this open-label research was to assess the safety, efficacy, and pharmacokinetics (PK) of crisaborole in babies aged 3 to 24 months with mild-to-moderate Alzheimer’s disease. Infants with mild (2) or moderate (3) Investigator’s Static Global Assessment (ISGA) and a percentage of treatable body surface area ( percent BSA) of 5 received crisaborole twice daily for 28 days; a group with moderate AD per ISGA and a percent BSA of 35 was included in a PK study. The key endpoints were safety, effectiveness, and PK (exploratory). There were 137 babies in all, with 21 from the PK cohort. 88 individuals had treatment-emergent adverse events (TEAEs). For 22 patients, TEAEs were judged treatment-related; the most commonly reported TEAEs were application site pain, discomfort, and erythema. 30.2 percent of patients obtained ISGA clear/almost clear with a 2-grade improvement on day 29.
The mean percentage change in Eczema Area and Severity Index score from baseline to day 29 was 57.5 percent, while the mean change in Patient-Oriented Eczema Measure total score was 8.5. Crisaborole systemic exposures in newborns were studied and found to be equivalent to those in individuals over the age of two.