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

Phase 4

Completed

• Conditions: Keratosis; Actinic Keratosis

• Registration Number: NCT00110682
• Lead Sponsor: Derm Research @ 888 Inc.

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-05-12
• Study First Submitted QC: 2005-05-12
• Study First Posted: 2005-05-13
• Primary Completion: 2006-10
• Study Completion: 2006-12
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-21
• Last Update Posted: 2008-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence rate and time to recurrence of lesions

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Windsor Clinical Research; 🇨🇦 Windsor, Ontario, Canada

Centre de Recherche Dermatologique, CRDQ; 🇨🇦 Sainte-Foy, Quebec, Canada

DermResearch @ 888 Inc; 🇨🇦 Vancouver, British Columbia, Canada