Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-02-12 @ 4:30 AM
Study NCT ID:
NCT00828568
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2009-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Two Imiquimod Cream 5%
Sponsor:
Sun Pharmaceutical Industries, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
Status:
COMPLETED
Status Verified Date:
2013-12
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:
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK.
The secondary objective is to compare the adverse event (AE) profiles of the two creams.
The secondary objective is to compare the adverse event (AE) profiles of the two creams.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: