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


CONCLUSIONS
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.
Friedlander
S F
SF
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.
Hebert
A A
AA
Allen
D B
DB
D000287:Administration, Topical; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D005260:Female; D000068298:Fluticasone; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007223:Infant; D008297:Male; D009824:Ointments; D012449:Safety; D013997:Time Factors
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D009824:Ointments; D000068298:Fluticasone; D006854:Hydrocortisone