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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  09/28/2007
 
Trade Name:  Lamisil Oral Granules
 
Generic or Proper Name (*):  terbinafine
 
Indications Studied:  Tinea capitis
 
Therapeutic Category:  Antifungal, topical
 
Ages Studied:  3-12 years
 
Study #:  3
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Active Control/Parallel Group
 
No Patients:  802
 
No Centers:  72
 
No Countries:  9
 
BPCA(B), PREA(P):  B
 
Asian:  1
 
Black:  409
 
Other:  204
 
White:  188
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  Brazil(2), Ecuador(3), Egypt(4), France(4), Guatemala(2), India(5), Russia(3), South Africa(1), US(48)
 
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