An Open-Label 18-Month Safety Study of Fluorouracil Cream 0.5% for the Treatment of Actinic Keratoses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00377273|
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : April 10, 2008
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratoses||Drug: fluorouracil cream 0.5%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2003|
|Study Completion Date :||October 2005|
- The reduction in Actinic Keratosis lesion counts on other body sites from pretreatment to post-treatment and AK clearance of other body site lesions for Treatment Cycle 1.
- The reduction in Actinic Keratosis lesion counts of the face (including anterior scalp, if applicable) from pretreatment to post-treatment and AK clearance of facial lesions for each Treatment Cycle
- The recurrence of facial lesions at 12 and 18 months post initial treatment, and the need for re-treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377273
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Phyllis Diener, MT, ASCP||Sanofi|