Safety of Fluticasone Propionate Cream 0.05% for the Treatment of Severe and Extensive Atopic Dermatitis in Children as Young as 3 Months

J Am Acad Dermatol. 2002 Mar;46(3):387-93. doi: 10.1067/mjd.2002.118337.

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 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase IV
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Androstadienes / administration & dosage*
  • Androstadienes / adverse effects
  • Androstadienes / therapeutic use
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use
  • Case-Control Studies
  • Child
  • Child, Preschool
  • Dermatitis, Atopic / drug therapy*
  • Female
  • Fluticasone
  • Humans
  • Hydrocortisone / blood
  • Infant
  • Male
  • Ointments
  • Safety
  • Time Factors

Substances

  • Androstadienes
  • Anti-Inflammatory Agents
  • Ointments
  • Fluticasone
  • Hydrocortisone