Fluocinolone Acetonide 0.01% in Peanut Oil: Safety and Efficacy Data in the Treatment of Childhood Atopic Dermatitis in Infants as Young as 3 Months of Age

Abstract

Fluocinolone acetonide 0.01% in a blend of refined peanut and mineral oils has been established as effective and safe treatment for atopic dermatitis in patients 2 years and older, including those with peanut sensitivity, for several years. We sought to study the safety of fluocinolone acetonide 0.01% oil and its potential for adrenal axis suppression in infants as young as 3 months of age. A controlled, open-label study was performed in children aged 3 months to 2 years with moderate to severe atopic dermatitis at two academic pediatric dermatology centers. Patients received topical fluocinolone acetonide 0.01% oil twice daily to affected areas involving a minimum of 20% body surface ratio for 4 weeks. Cortisol stimulation testing was performed at baseline and at the end of the treatment phase. Patients were monitored for medication use and adverse events. Efficacy was assessed using the Investigator Global Severity and Response scales. Thirty-two patients with moderate to severe atopic dermatitis were recruited into the study and 30 were evaluated with the Physician's Global Improvement Assessment tool. The mean body surface ratio treated for all age groups was 48%. Eighty-three percent of patients had marked or better improvement scores by week 2 and 96% by week 4, with 40% completely cleared. No adrenal suppression occurred in the 24 patients that met inclusion criteria for hypothalamus-pituitary axis (HPA) axis analysis. No relevant adverse events occurred. Results of this study support the safety and efficacy of fluocinolone acetonide 0.01% in refined peanut oil vehicle, for infants as young as 3 months of age with atopic dermatitis. No evidence of adrenal suppression or adverse local effects was demonstrated after 4 weeks of twice daily treatment.