An open-label adrenal suppression study of 0.1% fluocinonide cream in pediatric patients with atopic dermatitis.

OBJECTIVE: To assess the potential of a superhigh-potency 0.1% fluocinonide cream to suppress the hypothalamic-pituitary-adrenal (HPA) axis in pediatric patients with atopic dermatitis.
DESIGN: A multicenter, multiple-dose, open-label safety study in 4 age cohorts with 0.1% fluocinonide cream applied once or twice daily for 2 weeks.
SETTING: Clinical outpatient setting. PATIENTS: Patients with moderate to severe atopic dermatitis with 20% or more of the body surface area involved were included in the study. Each cohort began only after evaluation of the preceding cohort: ages 12 to younger than 18 years (cohort 1); 6 to younger than 12 years (cohort 2); 2 to younger than 6 years (cohort 3); and 3 months to younger than 2 years (cohort 4). MAIN OUTCOME MEASURES: Assessment of HPA axis suppression, local and systemic adverse events, and change in disease status from baseline.
RESULTS: Suppression of the HPA axis was not observed in any patient treated once daily for the 2 youngest cohorts. Suppression was observed in 1 (7%) of 15 and 2 (12%) of 16 patients in the fluocinonide twice-daily group in cohorts 1 and 2, respectively. In all 4 cohorts, more than 90% of patients in the fluocinonide once-daily and twice-daily groups showed improvement in their disease status.
CONCLUSIONS: Once-daily treatment with 0.1% fluocinonide cream for 2 weeks does not result in HPA axis suppression under the conditions of this study. Once-daily applications provided similar or better efficacy as twice-daily applications with a lower risk of HPA axis suppression. The frequency of HPA axis suppression is no greater in younger children than in older children. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN71227633.

RCT Entities:   Population Interventions Outcomes