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Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis

NCT01686152 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 589

Last updated 2020-11-24

Study results available
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Summary

To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the Vehicle cream.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Imiquimod Cream, 3.75%

DRUG

Zyclara®

OTHER

Vehicle of Test Product

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01686152 on ClinicalTrials.gov