- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00110682
Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
April 21, 2008 updated by: Derm Research @ 888 Inc.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V4C 6X4
- DermResearch @ 888 Inc
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-
Ontario
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Windsor, Ontario, Canada
- Windsor Clinical Research
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Quebec
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Sainte-Foy, Quebec, Canada, G1V 4X7
- Centre de Recherche Dermatologique, CRDQ
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Recurrence rate and time to recurrence of lesions
|
Secondary Outcome Measures
Outcome Measure |
---|
Time to reach treatment success
|
Percentage of patients who clear
|
Patient improvement assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
May 12, 2005
First Submitted That Met QC Criteria
May 12, 2005
First Posted (Estimate)
May 13, 2005
Study Record Updates
Last Update Posted (Estimate)
April 24, 2008
Last Update Submitted That Met QC Criteria
April 21, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DR 2004-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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