Who is sponsoring NCT01502020?

NCT01502020 is sponsored by Actavis Mid-Atlantic LLC.

What condition does NCT01502020 study?

NCT01502020 studies Actinic Keratoses.

What drugs are being tested in NCT01502020?

Interventions: imiquimod cream, 3.75%, Vehicle Cream, imiquimod cream, 3.75%.

What is the status of NCT01502020?

NCT01502020 is currently COMPLETED.

Last reviewed 2011-12-29 · How we verify

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses

NCT01502020 NA COMPLETED

Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp. The current clinical study is designed to evaluate the therapeutic equivalence of this formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation (Graceway Pharmaceuticals LLC).

Details

Lead sponsor	Actavis Mid-Atlantic LLC
Phase	NA
Status	COMPLETED
Enrolment	410
Start date	2011-02
Completion	2011-11

Conditions

Actinic Keratoses

Interventions

imiquimod cream, 3.75%
Vehicle Cream
imiquimod cream, 3.75%

Primary outcomes

Complete clearance rate — 8 weeks post treatment period
Complete clearance rate (treatment success) was defined as the proportion of subjects in a treatment group with 100% clearance of all AK lesions within the Treatment Area. The primary efficacy endpoint was the proportion of subjects in the per-protocol (PP) population with treatment success at Week 14/EOS. All AKs (Baseline and new lesions), independent of size, within the Treatment Area were included in the AK lesion counts.
Dosing Compliance — 8 weeks post treatment period
Measures of test article compliance included the total number of days of test article applications recorded on the CRFs and verified from the data in the subject diaries. Compliant subjects were defined as those who applied at least 75% and no more than 125% of the test article applications.
Adverse Events — 14 weeks
The severity and frequency of adverse events (AEs) were assessed in the three treatment groups.
Local Skin Reactions — 14 weeks
The severity and frequency of local skin reactions (LSRs) were assessed in the three treatment groups.

Countries

United States