Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335179
Status:
COMPLETED
Last Update Posted:
2010-07-23
First Post:
2006-06-08
Brief Title:
Cellular and Molecular Events During Treatment of Actinic Keratosis With Imiquimod 5 Cream
Sponsor:
Graceway Pharmaceuticals LLC
Organization:
Graceway Pharmaceuticals LLC
Study Overview
Official Title:
Double-Blind Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara Imiquimod Cream 5
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on and turned off by skin cells Some of the drug induced changes in skin cells should also be visible using a special microscope This study examines both types of changes
Detailed Description:
The primary objective of this study was to assess apoptosis by examining the gene expression profiles of actinic keratosis AK lesions that were treated with imiquimod 5 cream or vehicle cream once daily 3 times per week for 4 weeks Secondary objectives were to assess the utility of confocal microscopy CM to visually track cellular response to treatment with study cream compared with clinical and histological evaluations and to evaluate the safety of treatment with imiquimod in subjects with AK on the balding scalp
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None