5 July 2019 - - US-based drugmaker Pfizer Inc. (NYSE: PFE) has received top-line results from a Phase 4 study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged three months to less than 24 months with mild to moderate atopic dermatitis, also known as eczema, the company said.
The data from the trial are supportive of the primary study objective to examine the safety of crisaborole ointment, 2%, in this patient population, and are consistent with previous clinical trial experience.
Crisaborole ointment, 2%, is currently approved in select countries for mild to moderate AD in patients two years of age and older.
The primary endpoints of CrisADe CARE 1 were the number of patients with treatment-emergent adverse events and severe adverse events and number of patients with clinically significant changes from baseline in height, weight, vital signs, electrocardiogram, and clinical laboratory parameters.
Detailed analyses of the study will be submitted for presentation at a future scientific meeting.
Crisaborole ointment, 2%, is a novel, steroid-free, topical phosphodiesterase inhibitor.6 It is approved in the US and Canada as EUCRISA (crisaborole ointment, 2%) and Israel and Australia as Staquis (crisaborole ointment, 2%) for mild to moderate atopic dermatitis in patients two years of age and older.
The phase 4 crisaborole study (CrisADe CARE 1) was a 4-week, multicenter, open-label, single-arm study to evaluate the safety, pharmacokinetics, and efficacy of crisaborole ointment, 2%, applied twice daily in 125 pediatric patients who were three months to less than 24 months of age with mild to moderate atopic dermatitis involving at least 5% treatable body surface area, excluding the scalp.
A cohort of 16 of the 125 subjects were included in a subgroup for PK assessment, with clinical diagnoses of moderate AD and a minimum of 35% treatable percent BSA, excluding the scalp.
About Atopic Dermatitis is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Lesions of AD are characterised by erythema (redness), induration (hardening)/papulation (formulation of papules), and oozing/crusting.
AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.
A total of 45% of all AD cases begin within the first six months of life, 60% begin during the first year, and 85% begin before five years of age.
Approximately 50% of pediatric AD patients globally have recurrent symptoms into adolescence and adulthood.
Crisaborole ointment, 2%, is a novel, steroid-free, topical phosphodiesterase inhibitor.6 It is approved in the US and Canada as EUCRISA (crisaborole ointment, 2%) and Israel and Australia as Staquis (crisaborole ointment, 2%) for mild to moderate atopic dermatitis in patients two years of age and older.