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Bioequivalence Study of Two Imiquimod Cream 5%

NCT00828568 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2014-01-28

Study results available
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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.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Imiquimod 5% manufactured by Taro

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

DRUG

Aldara - Imiquimod 5%

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

DRUG

Imiquimod Vehicle manufactured by Taro

Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-03-31
Completion
2009-05-31

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 NCT00828568 on ClinicalTrials.gov