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 ].
There is no agreed treatment for topical corticosteroid withdrawal, apart from ceasing the topical corticosteroid. However whether this should be tapered or abrupt has not been determined. Japanese reports suggest there is minimal difference in the outcome, so recommend immediate cessation. A tapering course of oral steroids is helpful, as the addiction appears to relate only to the use of topical corticosteroids. Oral tetracyclines and low-dose isotretinoin have been used in steroid rosacea and perioral /periorificial dermatitis .