Safety and efficacy of desonide hydrogel 0.05% in pediatric subjects with atopic dermatitis.
Author(s): Hebert AA, Cook-Bolden FE, Basu S, Calvarese B, Trancik RJ, Desonide Hydrogel Study Group
Affiliation(s): Department of Dermatology, University of Texas Medical School, Houston, TX, USA.
Publication date & source: 2007-02, J Drugs Dermatol., 6(2):175-81.
Publication type: Clinical Trial, Phase III; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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.