Hydrocortisone butyrate 0.1% cream (proprietary lipid rich cream vehicle) does not significantly suppress hypothalamic-pituitary-adrenal axis and is effective in pediatric patients 3 months and older with extensive atopic dermatitis.

Only a few corticosteroids for topical use have been proven safe and effective in pediatric populations down to 3 months of age. The authors examined the systemic safety (adrenal suppression potential) of topically applied hydrocortisone butyrate 0.1% cream (proprietary lipid rich cream vehicle) in the treatment of moderate to severe atopic dermatitis in pediatric patients aged 3 months to 6 years and 12 years to 18 years. An open-label hypothalamic-pituitary-adrenal axis suppression study was conducted wherein the sole treatment was 0.1% proprietary lipid rich cream vehicle. A total of 65 patients with moderate to severe atopic dermatitis and body surface area involvement of at least 25% were included in the treatment phase of the study based on the requirement that these patients had normal baseline cortisol and hypothalamic-pituitary-adrenal system function. All signs and symptoms of atopic dermatitis showed progressive improvement beginning with day 8 through the day 29 evaluation. Pruritus showed the greatest improvement, with a decrease in grade of 1.3 at day 8, and continued to show improvement at day 29, with a decrease of 1.8 from baseline. The percent body surface area affected at baseline averaged 40.5%, and it decreased significantly to a mean of 6.5% at day 29. Only 5 (8%) of the 63 patients showed laboratory evidence of adrenal suppression at the end of the treatment evaluation. None of these ever demonstrated any clinical signs or symptoms of adrenal suppression. This study adds hydrocortisone butyrate 0.1% cream, to the short list of corticosteroids that have been proven effective and safe by the cosyntropin suppression test in children 3 months and older with widespread atopic dermatitis.