Safety of fluticasone propionate cream 0.05% for the treatment of severe and extensive atopic dermatitis in children as young as 3 months

Background: Topical corticosteroids are useful for the treatment of pediatric dermatoses. However, concerns regarding possible systemic and topical toxicities have limited the use of moderate-potency corticosteroids in children. Objective: Our purpose was to characterize the safety of fluticasone propionate cream in children. Methods: Children between 3 months and 5 years 11 months (n=32) and 3 up to 6 years of age (n=19) with moderate to severe atopic dermatitis (greater than or equal to35% body, surface area; mean body surface area treated, 64%) were treated with fluticasone propionate cream, 0.05% twice daily for 3 to 4 weeks. Serum cortisol response, fluticasone levels, skin changes, and adverse events were analyzed. Results: Mean cortisol levels were similar at baseline (13.76+/-6.94 mug/dL prestimulation and 30.53+/-7.23 mug/dL poststimulation) and at end of treatment (12.32+/-6.92 mug/dL prestimulation and 28.84+/-7.16 mug/dL poststimulation). Only 2 of 43 children had end-treatment poststimulation values less than 18.0 mug/dL. No significant adverse cutaneous effects were noted. Conclusion: Fluticasone propionate cream 0.05% appears to be safe for the treatment of severe eczema for up to 4 weeks in children 3 months of age and older.