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

Friedlander, S. F. MD
Hebert, A. A. MD
Allen, D. B. MD

San Diego, California, Houston, Texas, and Madison, Wisconsin
^aFrom the Department of Pediatrics and Medicine (Dermatology), University of California, San Diego School of Medicine and Children's Hospital; ^bthe Department of Dermatology, University of Texas Medical School, Houston; and ^cthe Department of Pediatrics, University of Wisconsin, Madison.

Accepted April 30, 2001.

Supported by Glaxo Wellcome Inc.

Conflict of interest: None.

Reprint requests: Sheila Fallon Friedlander, MD, 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.

^*A complete list of the members of the Fluticasone Pediatrics Safety Group appears at the end of the article.

Journal of the American Academy of Dermatology 46(3):p 387-393, March 2002.

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 (≥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 μg/dL prestimulation and 30.53 ± 7.23 μg/dL poststimulation) and at end of treatment (12.32 ± 6.92 μg/dL prestimulation and 28.84 ± 7.16 μg/dL poststimulation). Only 2 of 43 children had end-treatment poststimulation values less than 18.0 μg/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. (J Am Acad Dermatol 2002;46:387-93.)