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Generic Tazarotene Cream, 0.05% for the Treatment of Plaque Psoriasis

NCT02160665 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 866

Last updated 2016-11-03

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and efficacy profiles of Tazarotene Cream, 0.05% and Tazorac® (Tazarotene) Cream, 0.05% in order to demonstrate bioequivalence and to demonstrate the superiority of the 2 active creams over that of the Vehicle (placebo) in the treatment of plaque psoriasis.

Conditions

Interventions

DRUG

Tazarotene Cream, 0.05%

Tazarotene Cream, 0.05% (G \& W Laboratories, Inc.)

DRUG

Vehicle

Vehicle of Test product (G \& W Laboratories, Inc.)

DRUG

Reference: Tazorac Cream, 0.05%

Reference: Tazorac (tazarotene) Cream, 0.05% (Allergan, Inc.)

Sponsors & Collaborators

  • G & W Laboratories Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Bukhalo, MD · Altman Dermatology Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02160665 on ClinicalTrials.gov