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

Scalp Disorders

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 33175
    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

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