Safety and Efficacy of Desonide Hydrogel 0.05% in Pediatric Subjects with Atopic Dermatitis
February 2007 | Volume 6 | Issue 2 | 175 | Copyright © February 2007
Adelaide A. Hebert MD and Fran E. Cook-Bolden MD for the Desonide Hydrogel Study Group, Sarmistha Basu PhD, Barry Calvarese MS, Ronald J. Trancik PhD
Abstract
Low to mid potency corticosteroids remain a cornerstone of therapy for atopic dermatitis (AD). Since AD is most
prevalent in the younger pediatric population and is chronic in nature, safety is of particular concern especially for children
under 2 years of age. A novel desonide (0.05%) formulation was developed in a nonirritating and moisturizing
aqueous gel (hydrogel) that is free of alcohol and surfactants. The safety and efficacy of this new class VI low potency
topical steroid was substantiated in 2 phase III clinical trials in mild to moderate AD subjects aged 3 months to 18 years
(mean age 6.7 years and 30% under 3 years). A total of 425 subjects were treated with desonide hydrogel and 157 subjects
with the hydrogel vehicle. Desonide hydrogel 0.05% was extremely well-tolerated and provided statistically significant
improvements in all primary (P<.001) and secondary (P?.006) efficacy endpoints in both studies. This novel
desonide formulation represents an advancement in the treatment of AD. 
