Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
497
Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK.
Time frame: 24 weeks
The secondary objective is to compare the safety profiles of the three creams.
Time frame: 24 weeks
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Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks