Bioequivalence Study of Two Imiquimod Cream 5%

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

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.

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