Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
NCT ID: NCT00110682
Last Updated: 2008-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2005-04-30
2006-12-31
Brief Summary
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* 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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Imiquimod used as an adjunct to cryotherapy
Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential using appropriate contraceptive methods
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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3M
INDUSTRY
Derm Research @ 888 Inc.
INDUSTRY
Responsible Party
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Department of Dermatology and Skin Science
Principal Investigators
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Yves Poulin, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Centre de Recherche Dermatologique du Quebec Metropolitaine
Jerry KL Tan, MD FDRPC
Role: PRINCIPAL_INVESTIGATOR
U. of Western Ontario, Windsor Ontario
Richard Thomas, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Derm Research @ 888 Inc.
Locations
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DermResearch @ 888 Inc
Vancouver, British Columbia, Canada
Windsor Clinical Research
Windsor, Ontario, Canada
Centre de Recherche Dermatologique, CRDQ
Sainte-Foy, Quebec, Canada
Countries
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Other Identifiers
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DR 2004-05
Identifier Type: -
Identifier Source: org_study_id