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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Derm Research @ 888 Inc.
• Collaborator: 3M
• Treatments: Imiquimod

Criteria

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.