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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,☆☆,,★★

https://doi.org/10.1067/mjd.2002.118337Get rights and content

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 (≥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.)

Section snippets

Subjects

Pediatric patients between the ages of 3 months and 5 years 11 months with extensive moderate to severe psoriasis or eczema (excluding acute self-limiting eczema) were considered for enrollment. Their condition must have been stable or worsening and must have involved at least 35% of body surface area (BSA) (not counting lesions in the diaper area for subjects who wore diapers; also excluding lesions on the eyelids, in the perioral area, in the nostrils, and in areas where corticosteroid

Study population

Fifty-one children, 32 in the younger group (age 3-35 months; median, 20 months) and 19 in the older group (age 36-70 months; median, 50 months) were enrolled, all of whom had atopic dermatitis. In the younger group, 8 children were younger than 12 months (4 were 3-6 months and 4 were 7-11 months). Demographic and baseline dermatologic characteristics are shown in Tables I and II, respectively.

. Summary of baseline demographic and subject characteristics

Empty CellAge 3 mo to 2 yAge 3 to 5 yBoth age groups

Discussion

This phase IV open-label study demonstrated that fluticasone propionate cream 0.05% applied twice daily for 3 to 4 weeks over a large BSA (mean, 64%) has a low potential to suppress HPA axis function in children as young as 3 months of age who have moderate to severe eczema. Infrequently, HPA axis suppression can occur, and therefore periodic monitoring is appropriate in high-risk patients. Monitoring may be carried out by CST, morning plasma cortisol levels, and urine-free cortisol tests. If

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Supported by Glaxo Wellcome Inc.

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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.

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

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