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

Last updated: July 30, 2018
Sponsor: Fougera Pharmaceuticals Inc.
Overall Status: Completed

Phase

3

Condition

Warts

Skin Wounds

Rash

Treatment

N/A

Clinical Study ID

NCT02886702
0453-01-01
0453
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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) (notincluding the scalp and intertriginous areas)

  • Have a minimum plaque elevation at the target lesion site of at least moderateseverity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severelesion at baseline should be identified as the target lesion

  • Have an Investigator's Global Assessment (IGA) of disease severity of at leastmoderate (score ≥ 3) as an overall assessment of all lesions to be treated.

Exclusion

Exclusion Criteria:

  • A female subject who is pregnant, nursing, planning a pregnancy, or does not agree touse 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 Design

Total Participants: 855
Study Start date:
September 19, 2016
Estimated Completion Date:
August 02, 2017

Connect with a study center

  • Fougera Investigational Site

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Fougera Investigational Site

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Fougera Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Fougera Investigational Site

    North Hollywood, California 91606
    United States

    Site Not Available

  • Fougera Investigational Site

    San Diego, California 92108
    United States

    Site Not Available

  • Fougera Investigational Site

    San Ramon, California 94582
    United States

    Site Not Available

  • Fougera Investigational Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Fougera Investigational Site

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Fougera Investigational Site

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Fougera Investigational Site

    Miami, Florida 33143
    United States

    Site Not Available

  • Fougera Investigational Site

    Miami Gardens, Florida 33169
    United States

    Site Not Available

  • Fougera Investigational Site

    Miramar, Florida 33027
    United States

    Site Not Available

  • Fougera Investigational Site

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Fougera Investigational Site

    Tampa, Florida 33618
    United States

    Site Not Available

  • Fougera Investigational Site

    West Palm Beach, Florida 33406
    United States

    Site Not Available

  • Fougera Investigational Site

    Macon, Georgia 31217
    United States

    Site Not Available

  • Fougera Investigational Site

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Fougera Investigational Site

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Fougera Investigational Site

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Fougera Investigational Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Fougera Investigational Site

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Fougera Investigational Site

    Saint Joseph, Missouri 91606
    United States

    Site Not Available

  • Fougera Investigational Site

    St. Joseph, Missouri 91606
    United States

    Site Not Available

  • Fougera Investigational Site

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Fougera Investigational Site

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Fougera Investigational Site

    Salem, Oregon 97302
    United States

    Site Not Available

  • Fougera Investigational Site

    Hazelton, Pennsylvania 18201
    United States

    Site Not Available

  • Fougera Investigational Site

    Hazleton, Pennsylvania 18201
    United States

    Site Not Available

  • Fougera Investigational Site

    Upper Saint Clair, Pennsylvania 15241
    United States

    Site Not Available

  • Fougera Investigational Site

    Upper St. Clair, Pennsylvania 15241
    United States

    Site Not Available

  • Fougera Investigational Site

    San Antonio, Texas 78207
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.