A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis

July 30, 2018 updated by: Fougera Pharmaceuticals Inc.

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

855

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Fougera Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Fougera Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Fougera Investigational Site
      • North Hollywood, California, United States, 91606
        • Fougera Investigational Site
      • San Diego, California, United States, 92108
        • Fougera Investigational Site
      • San Ramon, California, United States, 94582
        • Fougera Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Fougera Investigational Site
      • Coral Gables, Florida, United States, 33134
        • Fougera Investigational Site
      • Hialeah, Florida, United States, 33016
        • Fougera Investigational Site
      • Miami, Florida, United States, 33015
        • Fougera Investigational Site
      • Miami, Florida, United States, 33143
        • Fougera Investigational Site
      • Miami, Florida, United States, 33175
        • Fougera Investigational Site
      • Miami Gardens, Florida, United States, 33169
        • Fougera Investigational Site
      • Miramar, Florida, United States, 33027
        • Fougera Investigational Site
      • Sweetwater, Florida, United States, 33172
        • Fougera Investigational Site
      • Tampa, Florida, United States, 33618
        • Fougera Investigational Site
      • West Palm Beach, Florida, United States, 33406
        • Fougera Investigational Site
    • Georgia
      • Macon, Georgia, United States, 31217
        • Fougera Investigational Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Fougera Investigational Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Fougera Investigational Site
      • Plainfield, Indiana, United States, 46168
        • Fougera Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Fougera Investigational Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Fougera Investigational Site
    • Missouri
      • Saint Joseph, Missouri, United States, 91606
        • Fougera Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Fougera Investigational Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Fougera Investigational Site
    • Oregon
      • Salem, Oregon, United States, 97302
        • Fougera Investigational Site
    • Pennsylvania
      • Hazleton, Pennsylvania, United States, 18201
        • Fougera Investigational Site
      • Upper Saint Clair, Pennsylvania, United States, 15241
        • Fougera Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78207
        • Fougera Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)
  • Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe lesion at baseline should be identified as the target lesion
  • Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.

Exclusion Criteria:

  • A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period
  • Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
  • Have a history of psoriasis unresponsive to topical treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
Drug: Tazarotene Cream 0.05%
Tazarotene Cream 0.05% to cover only the lesions with a thin film.
Other Names:
  • Tazarotene
Active Comparator: Reference
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
Drug: TAZORAC® (tazarotene) Cream 0.05%
TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
Other Names:
  • Tazarotene
Placebo Comparator: Placebo
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Drug: Placebo
Placebo (vehicle of the test product) to cover only the lesions with a thin film.
Other Names:
  • Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Success Assessed by IGA
Time Frame: Week 12
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Severity None or Minimal on IGA
Time Frame: Week 12
Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).
Week 12
Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
Time Frame: Week 12
Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fougera Pharmaceuticals Inc.

Investigators

  • Study Director: Angela C. Kaplan, Fougera Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2016

Primary Completion (Actual)

August 2, 2017

Study Completion (Actual)

August 2, 2017

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0453-01-01
  • 0453 (Other Identifier: Fougera Pharmaceuticals Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plaque Psoriasis

Clinical Trials on Tazarotene Cream 0.05%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe