Evaluation of Adrenal Suppression of a Lipid Enhanced, Topical Emollient Cream Formulation of Hydrocortisone Butyrate 0.1% in Treating Children with Atopic Dermatitis Lawrence Eichenfield, M.D.,*Charles N. Ellis, M.D.,David Fivenson, M.D.,à Adelaide A. Hebert, M.D.,§ Syd Dromgoole, Ph.D.,– and Daniel Piacquadio, M.D.** *Rady Children’s Hospital — San Diego, San Diego, California, Department of Dermatology, University of Michigan Medical School, Ann Arbor, Michigan, àDermatology PLLC, Ann Arbor, Michigan, §Department of Dermatology and Pediatrics, University of Texas Medical School — Houston, Houston, Texas, –Therapeutics, Inc., San Diego, California, **Division of Dermatology, and Divisions of Dermatology and Pediatric Dermatology, University of California, San Diego, San Diego, California Abstract: Corticosteroids are currently the first line of treatment for patients with atopic dermatitis. In the pediatric population however, the potential impact of adrenal suppression is always an important safety con- cern. Twenty boys and girls, 5–12 years of age, with normal adrenal function and a history of atopic dermatitis were maximally treated three times daily with a lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% for up to 4 weeks. At the conclusion of the 4-week treatment period, cosyntropin injection stimulation testing showed no evidence of adrenal suppression. In addition, the therapy was noted to be highly efficacious, with a clinical suc- cess rate of 80% (Physician Global Score of (0) clear or (1) almost clear). No local side effects associated with prolonged use of topical corticosteroids were reported. In summary, this study supports the contention that this lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% was a well-tolerated and beneficial treatment for atopic dermatitis, demonstrating no adrenal suppression in the pediatric population aged 5–12 years. The relevance of these findings for children below 5 years of age, because of difference in body mass/surface area ratios, remains to be determined. Effective management of chronic, recurrent inflam- matory diseases of the skin in children can reduce the severity and duration of intermittent flare-ups, and contribute to a quality of life comparable with that of individuals unaffected by disease. Estimates of the pre- valence of atopic dermatitis (AD) vary from 10% to 17% (1,2), with 87% of children with the disease exhibiting signs and symptoms by 5 years of age (3). In many cases Address correspondence to Daniel Piacquadio, M.D., Thera- peutics Inc., 9025 Balboa Avenue, Suite 100, San Diego, CA 92123, or e-mail: dfreeman@therapeuticsinc.com. Ó 2007 The Authors. Journal compilation Ó 2007 Blackwell Publishing, Inc. 81 Pediatric Dermatology Vol. 24 No. 1 81–84, 2007