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Sponsored by: |
MEDA Pharma GmbH & Co. KG |
Information provided by: | MEDA Pharma GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00294320 |
The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.
Condition | Intervention | Phase |
Actinic Keratosis |
Drug: Aldara (Imiquimod) Other: Vehicle cream |
Phase III |
Drug Information available for: | S 26308 |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study to Evaluate Two Different Non-Invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions (Clinical and Sub-Clinical), When Treated With Aldara 5% (Imiquimod) Cream |
Enrollment: | 12 |
Study Start Date: | February 2006 |
Study Completion Date: | January 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
250mg of Imiquimod cream application once daily 3 times per week.
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Drug: Aldara (Imiquimod)
250mg of Imiquimod cream for application once daily 3 times per week.
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2: Placebo Comparator
250mg vehicle cream for application once daily 3 times per week.
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Other: Vehicle cream
250mg vehicle cream for application once daily 3 times per week.
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Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In addition a qualitative assessment of each technique will be made for performance and ease of use.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Laboratoires 3M Santé ( Dr Elena Rizova MD. PhD Medical & Scientific Affairs Europe & MENA ) |
Study ID Numbers: | 1517-IMIQ |
First Received: | February 21, 2006 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00294320 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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