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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/12/2007
 
Trade Name:  Derma-Smoothe/FS Topical Oil
 
Generic or Proper Name (*):  fluocinolone
 
Indications Studied:  Treatment of atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks
 
Therapeutic Category:  Anti-inflammatory, topical
 
Ages Studied:  3 months and older
 
Study #:  1
 
Study Type:  Safety
 
Study Design:  Open Label
 
No Patients:  32
 
No Centers:  2
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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