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Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.

NCT01788007 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 443

Last updated 2014-01-22

No results posted yet for this study

Summary

The objective of this study is to compare the relative efficacy and safety of the test formulation Imiquimod 3.75% Topical Cream to the marketed formulation Zyclara® (imiquimod) 3.75% Topical Cream in the treatment of actinic keratosis. Both the test and reference formulations will also be compared to a placebo cream to test for superiority.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Imiquimod Topical Cream 3.75%

Imiquimod Topical Cream 3.75% (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.

DRUG

Zyclara® (imiquimod) Topical Cream 3.75%

Zyclara® (imiquimod) Topical Cream 3.75% (Medicis Pharmaceutical Co.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.

DRUG

Vehicle Topical Cream

Vehicle Topical Cream (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-10-31
Completion
2013-12-31

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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 NCT01788007 on ClinicalTrials.gov