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A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

NCT00859105 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 497

Last updated 2009-03-10

No results posted yet for this study

Summary

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study

Conditions

  • Actinic Keratosis

Interventions

DRUG

Imiquimod 5%: manufactured by Apotex

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

DRUG

Adara 5% Cream US

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

DRUG

Adara 5% Cream Canada

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

DRUG

Imiquimod Vehicle

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

Sponsors & Collaborators

  • Apotex Inc.

    lead INDUSTRY

Principal Investigators

  • William Brooks · Apotex Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-11-30

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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 NCT00859105 on ClinicalTrials.gov