S F Friedlander1, A A Hebert, D B Allen. 1. Department of Pediatrics and Medicine (Dermatology), University of California-San Diego School of Medicine and Children's Hospital San Diego, 3030 Children's Way, Suite 408, San Diego, CA 92123, USA.
Abstract
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 (> or =35% body surface area; mean body surface area treated, 64%) were treated withfluticasone 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 microg/dL prestimulation and 30.53 +/- 7.23 microg/dL poststimulation) and at end of treatment (12.32 +/- 6.92 microg/dL prestimulation and 28.84 +/- 7.16 microg/dL poststimulation). Only 2 of 43 children had end-treatment poststimulation values less than 18.0 microg/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.
RCT Entities:
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 (> or =35% 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 microg/dL prestimulation and 30.53 +/- 7.23 microg/dL poststimulation) and at end of treatment (12.32 +/- 6.92 microg/dL prestimulation and 28.84 +/- 7.16 microg/dL poststimulation). Only 2 of 43 children had end-treatment poststimulation values less than 18.0 microg/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.
Authors: John Berth-Jones; Robert J Damstra; Stefan Golsch; John K Livden; Oliver Van Hooteghem; Fulvio Allegra; Christine A Parker Journal: BMJ Date: 2003-06-21
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