Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic Keratoses

Inclusion Criteria:

• At least 18 years of age.
• Have a total of 4 to 8 clinically typical, discrete, non-hyperkeratotic, non-hypertrophic AK lesions located within a contiguous 25 cm2 treatment area (balding scalp or face, but not both).
• Free of any significant findings (e.g. tattoos) in the potential application site area that may impair examination of treatment or surrounding area.
• Willing to eliminate tanning bed/sun parlor use for duration of study.

Exclusion Criteria:

• Evidence of clinically significant, unstable cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease.
• Any dermatological disease and or condition in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (e.g. rosacea, psoriasis, atopic dermatitis, eczema).
• Confirmed SCC, BCC anywhere on the head.
• Share a household where there is a person participating in a concurrent clinical study of imiquimod or being treated with imiquimod 5% topical cream.
• Active chemical dependency or alcoholism, as assessed by investigator.
• Females who are pregnant, breast-feeding or considering becoming pregnant while on the study.
• Females with childbearing unwilling to practice an effective method of contraception, as defined by the investigator for the duration of the study as well as one month after completion.
• Received any treatment, products or procedures within the designated time period prior to the prestudy visit as listed on page 4 of the protocol (Version 03 dd March 2003).