Who is sponsoring NCT00828568?

NCT00828568 is sponsored by Sun Pharmaceutical Industries, Inc..

What condition does NCT00828568 study?

NCT00828568 studies Actinic Keratosis.

What drugs are being tested in NCT00828568?

Interventions: Imiquimod 5% manufactured by Taro, Aldara - Imiquimod 5%, Imiquimod Vehicle manufactured by Taro.

What is the status of NCT00828568?

NCT00828568 is currently COMPLETED.

Last reviewed 2013-12-21 · How we verify

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

NCT00828568 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Sun Pharmaceutical Industries, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	425
Start date	2008-06
Completion	2009-05

Conditions

Actinic Keratosis

Interventions

Imiquimod 5% manufactured by Taro
Aldara - Imiquimod 5%
Imiquimod Vehicle manufactured by Taro

Primary outcomes

Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5% — 24 weeks
Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline — 24 weeks
Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.

Countries

United States