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Sponsors and Collaborators: |
Derm Research @ 888 Inc. 3M |
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Information provided by: | Derm Research @ 888 Inc. |
ClinicalTrials.gov Identifier: | NCT00110682 |
Study Aims:
Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.
Condition | Intervention | Phase |
---|---|---|
Keratosis Actinic Keratosis |
Drug: Imiquimod used as an adjunct to cryotherapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | April 2005 |
Study Completion Date: | December 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
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:
Study Design: 6 visits over 62 weeks
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, British Columbia | |
DermResearch @ 888 Inc | |
Vancouver, British Columbia, Canada, V4C 6X4 | |
Canada, Ontario | |
Windsor Clinical Research | |
Windsor, Ontario, Canada | |
Canada, Quebec | |
Centre de Recherche Dermatologique, CRDQ | |
Sainte-Foy, Quebec, Canada, G1V 4X7 |
Principal Investigator: | Yves Poulin, MD FRCPC | Centre de Recherche Dermatologique du Quebec Metropolitaine |
Principal Investigator: | Jerry KL Tan, MD FDRPC | U. of Western Ontario, Windsor Ontario |
Principal Investigator: | Richard Thomas, MD FRCPC | Derm Research @ 888 Inc. |
Responsible Party: | Department of Dermatology and Skin Science ( D Richard Thomas ) |
Study ID Numbers: | DR 2004-05 |
Study First Received: | May 12, 2005 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00110682 |
Health Authority: | Canada: Health Canada |
Actinic Keratosis Cryotherapy Imiquimod |
Keratosis Skin Diseases Interferons Imiquimod Tylosis |
Interferon Inducers Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |