Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands

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

The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand when the cream is applied once daily 2 days per week for 16 weeks.

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