A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)

Last updated: October 24, 2018
Sponsor: Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Scalp Disorders

Rash

Treatment

N/A

Clinical Study ID

NCT02368210
122-0551-306
  • Ages > 18
  • All Genders

Study Summary

This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%and no more than 12% affected body surface area.

  • Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start.

  • If subject is a woman of childbearing potential, she must have a negative urinepregnancy test and agree to use an effective form of birth control for the duration ofthe study.

Exclusion

Exclusion Criteria:

  • Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

  • Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

  • Subject has a physical condition which, in the investigator's opinion, might impairevaluation of plaque psoriasis, or which exposes the subject to an unacceptable riskby study participation.

  • Subject has used any phototherapy (including laser), photo-chemotherapy or other formsof photo based therapy for the treatment of their psoriasis within 30 days prior tostudy start.

  • Subject has used any systemic methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids],cyclosporine or analogous products within 90 days prior to study start.

  • Subject has used any systemic biologic therapy (i.e., FDA-approved or experimentaltherapy) within five half-lives of the biologic prior to study start.

  • Subject had prolonged exposure to natural or artificial sources of ultravioletradiation within 30 days prior to study start or is intending to have such exposureduring the study.

Study Design

Total Participants: 151
Study Start date:
January 01, 2015
Estimated Completion Date:
February 28, 2017

Connect with a study center

  • Center for Dermatology Clinical Research

    Fremont, California 94538
    United States

    Site Not Available

  • International Dermatology Research, Inc.

    Miami, Florida 33144
    United States

    Site Not Available

  • Altman Dermatology Associates

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Academic Dermatology Associates

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Dermatology Associates of Knoxville

    Knoxville, Tennessee 37917
    United States

    Site Not Available

  • The Center for Skin Research

    Houston, Texas 77056
    United States

    Site Not Available

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 23507
    United States

    Site Not Available

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