A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

Study Overview
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Brief Summary
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Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study

Official Title
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A Multicenter, Double-Blind, Vehical-Controlled Study Comparing Imiquimod Cream, 5% (Apotex Inc.) to Aldara™ Cream, 5%(3M Pharmaceutials, U.S.) and Aldara™ Cream, 5%(3M Pharmaceuticals, Canada) in the Treatments of Actinic Keratosis.

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Imiquimod 5%: manufactured by Apotex
* Drug: Adara 5% Cream US
* Drug: Adara 5% Cream Canada
* Drug: Imiquimod Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control Free of any systemic or dermatological disorder Any skin type or race, providing the skin pigmentation will allow discernment of erythema Exclusion Criteria: Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp) History of cutaneous hyperreactivity or facial irritation to topical products Engaging in activities involving excessive or prolonged exposure to sunlight Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry Currently using or have used systemic steroids 2 months prior to study Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization Pregnant or nursing mothers History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation Taking immunosuppressant medication
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imiquimod 5%<br>Manufactured by Apotex | Drug: Imiquimod 5%: manufactured by Apotex<br>* Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks<br>|
| Active Comparator: Adara 5 % Cream US<br>Manufactured by 3M, US. | Drug: Adara 5% Cream US<br>* Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks<br>|
| Active Comparator: Adara 5% Cream Canada<br>Manufactured by 3M, Canada | Drug: Adara 5% Cream Canada<br>* Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.<br>|
| Placebo Comparator: Vehicle<br>Manufactured by Apotex | Drug: Imiquimod Vehicle<br>* Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective is to compare the safety profiles of the three creams. |  | 24 weeks |