Desonide, a low potency
corticosteroid, has been used widely as a topical treatment for inflammatory
dermatoses for over 30 years. A recent formulation advance has enabled the development of
desonide 0.05% into a novel moisturizing aqueous gel (
hydrogel) that is free of alcohol and
surfactants. This multicenter, open-label study evaluated the hypothalamic-pituitary-adrenal axis suppression potential, tolerability, and efficacy of this new Class VI topical
steroid formulation in pediatric subjects with moderate-to-severe
atopic dermatitis (mean body surface area = 51%). Forty children, aged 6 months to 6 years were enrolled and treated twice daily for 4 weeks.
Desonide hydrogel 0.05% was well tolerated and no treatment-related adverse events were reported. No suppression of adrenal function was observed in subjects who completed the study without protocol violations related to
cosyntropin administration or
cortisol testing (n=34). Of the subjects who completed the study with complications in
cortisol testing (n=3), there was one subject (1/37=3%) who had a low poststimulation
cortisol level at week 4. Efficacy was demonstrated by marked improvement in overall disease state and in the signs and symptoms of
atopic dermatitis. This study validates the systemic safety of a novel
desonide hydrogel formulation in young pediatric patients and confirms the longstanding tolerability and efficacy profile of
desonide.