Ninety-seven pediatric subjects ages 6 to 23 months with atopic dermatitis were enrolled in an open-label HPA axis safety study. ELOCON Cream was applied once daily for approximately 3 weeks over a mean body surface area of 41% (range 15%-94%). In approximately 16% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with ELOCON Cream. The criteria for suppression were: basal cortisol level of ≤ 5 mcg/dL, 30-minute post-stimulation level of ≤ 18 mcg/dL, or an increase of < 7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5 of the subjects, demonstrated suppressed HPA axis function in one subject, using these same criteria [see Use in Specific Populations ].
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