The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK. The secondary objective is to compare the adverse event (AE) profiles of the two creams.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
425
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
Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks
Investigator Site
Gilbert, Arizona, United States
Investigator Site
Tempe, Arizona, United States
Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%
Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
Time frame: 24 weeks
Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline
Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
Time frame: 24 weeks
Patients Reporting at Least One Adverse Event
For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.
Time frame: 24 weeks
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Investigator Site
Tuscon, Arizona, United States
Investigator Site
Denver, Colorado, United States
Investigator Site
Jacksonville, Florida, United States
Investigator Site
Miami, Florida, United States
Investigator Site
Evansvill, Indiana, United States
Investigator Site
Plainfield, Indiana, United States
Investigator Site
Olathe, Kansas, United States
Investigator Site
Wichita, Kansas, United States
...and 10 more locations