Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Upper Extremities

Inclusion Criteria:

- 18 years of age

- Have AK on arm or hand

- Discontinuation of sun tanning and the use of tanning beds

- Discontinuation of the use of moisturizers, body oils, over-the-counter retinol
products and products containing alpha or beta hydroxy acid in the treatment and
surrounding area

- Withholding of the use of sunscreen in the treatment area for 24 hours prior to all
study visits and for 8 hours before applying study cream

- Postponement of the treatment of non-study AK lesions anywhere on the arm being
treated until study participation is complete

Exclusion Criteria:

- Subjects must not have any evidence of systemic cancer or immunosuppression or other
unstable health conditions

- Participation in another clinical study

- Have previously received treatment with imiquimod within the treatment area

- Have squamous cell carcinoma (SCC), basal cell carcinoma (BCC), or other malignancy
in the treatment or surrounding area that requires treatment