To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
28 days of daily application
J&S Studies
College Station, Texas, United States
PK parameters (AUC, Cmax, Tmax, t1/2) will be measured at days 1 (Baseline), 9, 15 and 29. Safety assessments include monitoring of adverse events, local site tolerability, ECG monitoring, and changes in laboratory values and vital signs.
Time frame: March 2011
Evaluation of linear toenail growth.
Time frame: March 2011
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