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

AbstractBACKGROUND: 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.
AuthorsS F Friedlander, A A Hebert, D B Allen, Fluticasone Pediatrics Safety Study Group (Affiliation: 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.)
JournalJournal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 46 Issue 3 Pg. 387-93 (Mar 2002) ISSN: 0190-9622 United States
PMID11862174 (Publication Type: Clinical Trial, Clinical Trial, Phase IV, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Androstadienes
  • Anti-Inflammatory Agents
  • Ointments
  • Hydrocortisone
  • fluticasone
Topics
  • Administration, Topical
  • Androstadienes (administration & dosage, adverse effects, therapeutic use)
  • Anti-Inflammatory Agents (administration & dosage, adverse effects, therapeutic use)
  • Case-Control Studies
  • Child
  • Child, Preschool
  • Dermatitis, Atopic (drug therapy)
  • Female
  • Humans
  • Hydrocortisone (blood)
  • Infant
  • Male
  • Ointments
  • Safety
  • Time Factors