A Randomized Study of Imiquimod 5% Cream as an Adjunct to Cryotherapy in the Management of Actinic Keratosis

Unique ID:   2005-001

TITLE:

A Randomized Study of Imiquimod 5% Cream as an Adjunct to Cryotherapy in the Management of Actinic Keratosis

Dates:

Registration Date:   April 2005
Anticipated / Actual Start Date:   April 2005
Anticipated Or Actual Date Of Last Follow-Up:   December 2006
Planned Or Actual Date Of Closure To Data Entry:   June 2007
Date Trial Data Considered Complete:   December 2007

Health Authority:   Health Canada
Corporate Sponsor:   3M Pharmaceuticals
Investigator:   Derm Research @ 888 Inc.

Clinical Trial Details:

• Evaluation of (i) topical imiquimod 5% cream or (ii) vehicle cream used two times weekly for eight weeks starting two weeks post cryotherapy
• To assess and compare the recurrence rate and time

• The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses compared to the vehicle arm.

• Recurrence rate and time to recurrence of lesions

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

Study Description:

Study Duration:   6 visits over 62 weeks
Study Phase:   Phase 3
Study Type:   Interventional
Study Design:
Study Purpose   Treatment
Allocation   Randomized
Masking   Double blind
Control   Placebo control
Assignment   Parallel assignment
Endpoints   Safety / efficacy study
Conditions:   Keratosis

Eligibility Criteria:

• Gender: Both
• Minimum Age: 18 years old
• Maximum Age: N/A
• Requires Healthy Volunteers: No
• Expected Enrollment: 60

Inclusion Criteria:

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

Exclusion Criteria:

• Previous treatments with imiquimod for AK in the prescribed amount 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 amount in the past 2 years

Contact information for the principal investigator:

Facility:   DermResearch @ 888 Inc.
Location:   Vancouver, BC, Canada
Contact:   Frances Maddin
Phone:   604-873-4049
Email:   trials@dermatologyresearch.com
Investigator:   Richard Thomas, MD, FRCPC
Role:   Principal Investigator
Date of Posting:   May 24, 2005
Last Date Updated: