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Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis

NCT00948428 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2020-09-04

Study results available
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Summary

At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.

Conditions

  • Actinic Keratoses

Interventions

DRUG

imiquimod

5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

DRUG

Aldara™

5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

DRUG

Vehicle Cream

Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Christine M. Winslow, Ph.D. · Actavis Mid-Atlantic LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-03-31
Completion
2009-04-30

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 NCT00948428 on ClinicalTrials.gov