Desonide foam 0.05%: Safety in children as young as 3 months

BackgroundDesonide 0.05% was recently developed in an emulsion foam formulation.ObjectiveThe safety of desonide foam 0.05% in children aged 3 months to 17 years was evaluated in two phase II studies and one phase III study.MethodsA phase II open-label study of the effect of desonide foam 0.05% on the hypothalamic-pituitary-adrenal axis was evaluated in pediatric and adolescent participants with mild-to-moderate atopic dermatitis. The phase II and III clinical efficacy studies evaluated adverse events.ResultsAt the end of the 4-week treatment in the phase II study, 4% (3 of 75) of participants experienced mild, reversible hypothalamic-pituitary-adrenal–axis suppression. The combined safety data from the phase II and III studies revealed 6% of participants in the desonide foam group and 14% in the vehicle foam group reported adverse events (P = .0002), with application site burning as the most commonly reported adverse event (3% in the desonide foam group vs 7% in the vehicle foam group; P = .004).LimitationsThe studies evaluated short-term use only.ConclusionDesonide foam was safe and well tolerated in participants as young as 3 months.