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

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