Evaluation of Adrenal Suppression of a Lipid Enhanced, Topical Emollient Cream Formulation of Hydrocortisone Butyrate 0.1% in Treating Children with Atopic Dermatitis


Address correspondence to Daniel Piacquadio, M.D., Therapeutics Inc., 9025 Balboa Avenue, Suite 100, San Diego, CA 92123, or e-mail: dfreeman@therapeuticsinc.com.


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 concern. 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 success 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.