The purpose of this study it so compare the safety and efficacy profiles of a generic imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of actinic keratosis (AK).
Aldara® (imiquimod) Cream, 5% was the first imiquimod product approved by the Food and Drug Administration (FDA) for the topical treatment of AK, superficial basal cell carcinoma and external genital and perianal warts. The FDA approved regimen for the treatment of AK is application of 250 milligrams (mg) of cream twice a week for 16 weeks to a 25 square centimeters (cm\^2) area. In 2011, a lower strength imiquimod cream, Zyclara (imiquimod) Cream, 2.5% was approved by the FDA. When used for the treatment of AK, Zyclara is applied for a shorter duration and in an expanded treatment area (for example, face or scalp) in comparison to Aldara®. This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirement(s). Marketed by Medicis, Zyclara® (imiquimod) cream 2.5% is a safe and effective topical therapy for the treatment of AK of the face and scalp. Actavis has developed a generic formulation of imiquimod 2.5% cream and the current study is designed to evaluate the safety and efficacy of this formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
467
Cream, generic formulation of the brand product.
Cream, brand product.
Vehicle cream in the same image of the generic imiquimod. Has no active ingredient.
Site 1
Birmingham, Alabama, United States
Complete Clearance Rate - Percentage of Participants With Treatment Success: Per-Protocol (PP) Population
Complete clearance rate (treatment success) was defined as the percentage of participants in each treatment group with a count of zero actinic keratosis (AK) lesions in the treatment area at Week 14. All AKs (baseline and new lesions) independent of size within the treatment area were included in the efficacy lesion count. The AK clearance rate for a participant was calculated as follows: {1 - \[ (number of AK lesions at Week 14) / (number of AK lesions at Baseline)\]} \* 100.
Time frame: Week 14
Complete Clearance Rate - Percentage of Participants With Treatment Success: ITT Population
Complete clearance rate (treatment success) was defined as the percentage of participants in each treatment group with a count of zero AK lesions in the treatment area at Week 14. All AKs (baseline and new lesions) independent of size within the treatment area were included in the efficacy lesion count. The AK clearance rate for a participant was calculated as follows: {1 - \[ (number of AK lesions at Week 14) / (number of AK lesions at Baseline)\]} \* 100.
Time frame: Week 14
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Mild AEs: awareness of sign or symptom, but easily tolerated. Moderate AEs: discomfort sufficient to cause interference with normal activities. Severe AEs: inability to carry out usual activities. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline (Day 1) up to Week 14
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Site 10
Fremont, California, United States
Site 8
Los Angeles, California, United States
Site 24
Denver, Colorado, United States
Site 28
Boca Raton, Florida, United States
Site 26
Brandon, Florida, United States
Site 27
Brandon, Florida, United States
Site 21
Boise, Idaho, United States
Site 3
Arlington Heights, Illinois, United States
Site 17
Champaign, Illinois, United States
...and 17 more locations
Number of Participants With Local Skin Reactions
Local skin reactions included erythema, flaking/scaling/dryness, scabbing/crusting, pruritus, erosion/ulceration, pain, edema, and weeping/exudate. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline (Day 1) up to Week 14