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

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.

• Authors: S F Friedlander, A A Hebert, D B Allen, Fluticasone Pediatrics Safety Study Group
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 46 Issue 3 Pg. 387-93 (Mar 2002) ISSN: 0190-9622 [Print] United States
• PMID: 11862174 (Publication Type: Clinical Trial, Clinical Trial, Phase IV, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

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

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
• Fluticasone
• Humans
• Hydrocortisone (blood)
• Infant
• Male
• Ointments
• Safety
• Time Factors