Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2006

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

Intervention(s) in this Clinical Trial

• Drug: Imiquimod used as an adjunct to cryotherapy

Primary Measures

• Recurrence rate and time to recurrence of lesions

Secondary Measures

• Time to reach treatment success
• Percentage of patients who clear
• Patient improvement assessment

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Derm Research @ 888 Inc.

Overall Clinical Trial Officials and Contacts

Yves Poulin, MD FRCPC Principal Investigator Centre de Recherche Dermatologique du Quebec Metropolitaine  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00110682

Study ID Number: DR 2004-05

ClinicalTrials.gov Identifier: NCT00110682

Health Authority: Canada: Health Canada