Who is sponsoring NCT01788007?

NCT01788007 is sponsored by Sun Pharmaceutical Industries, Inc..

What condition does NCT01788007 study?

NCT01788007 studies Actinic Keratosis.

What drugs are being tested in NCT01788007?

Interventions: Imiquimod Topical Cream 3.75%, Zyclara® (imiquimod) Topical Cream 3.75%, Vehicle Topical Cream.

What is the status of NCT01788007?

NCT01788007 is currently COMPLETED.

Last reviewed 2014-01-19 · How we verify

A Randomized, Double Blind, Placebo Controlled, Parallel Design, Multiple Site, Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.

NCT01788007 Phase 1 COMPLETED

The objective of this study is to compare the relative efficacy and safety of the test formulation Imiquimod 3.75% Topical Cream to the marketed formulation Zyclara® (imiquimod) 3.75% Topical Cream in the treatment of actinic keratosis. Both the test and reference formulations will also be compared to a placebo cream to test for superiority.

Details

Lead sponsor	Sun Pharmaceutical Industries, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	443
Start date	2013-01
Completion	2013-12

Conditions

Actinic Keratosis

Interventions

Imiquimod Topical Cream 3.75%
Zyclara® (imiquimod) Topical Cream 3.75%
Vehicle Topical Cream

Primary outcomes

Treatment success — Week 14 (8 weeks after completion of treatment)
Treatment success will be defined by the proportion of patients in the per protocol population with 100% clearance of all actinic keratosis lesions within the treatment area at study week 14 (8 weeks after completion of treatment.)