Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses

A Randomized, Parallel-Group, Vehicle-Controlled, Double-Blind Study of Topical Imiquimod 5% Cream Used as an Adjunct to Cryotherapy in the Management of Actinic Keratoses, With a Long-Term (1 Year) Follow-Up

Study Aims:

• To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy.
• To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.

Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.

Evaluation of: (i) topical imiquimod 5% cream or (ii) vehicle cream used two times weekly for eight weeks starting two weeks post cryotherapy.

Study Aims:

• To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.
• To assess and compare the efficacy of the 2 different treatment groups.
• To assess and compare the safety of the 2 different treatment groups.

Study Design: 6 visits over 62 weeks

Inclusion Criteria:

• Diagnosis of actinic keratosis with 4 or more discreet lesions on the face or balding scalp. Lesions must be within a treatment area not exceeding 50 cm2 (combined total must not exceed 50 cm2)
• Women of childbearing potential using appropriate contraceptive methods

Exclusion Criteria:

• Previous treatments with imiquimod for AK in the prescribed area within the past 5 months or cryosurgery in the same area within the past 4 weeks.
• Patients unwilling to stay out of the sun or wear protective clothing or to use sunscreen with a minimum of SPF 15 during the study.
• Basal or squamous cell carcinomas in the prescribed treatment area in the past 2 years.