A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 000-0551 Lotion; Vehicle Lotion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; lotion; investigator's global assessment

Summary:

      This Phase 3 study has been designed to determine and compare the efficacy and safety of
      000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque
      psoriasis.
    

Eligibility criteria:

        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 urine
             pregnancy test and agree to use an effective form of birth control for the duration of
             the study.

        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 used any phototherapy (including laser), photo-chemotherapy or other forms
             of photo based therapy for the treatment of their psoriasis within 30 days prior to
             study 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 experimental
             therapy) within five half-lives of the biologic prior to study start.

          -  Subject had prolonged exposure to natural or artificial sources of ultraviolet
             radiation within 30 days prior to study start or is intending to have such exposure
             during the study.

          -  Subject has used topical body (excluding the scalp) psoriasis therapy (including coal
             tar, anthralin, steroids, retinoids, vitamin D analogs) within 14 days prior to study
             start.

          -  Subject has used emollients/moisturizers on areas to be treated within four hours
             prior to clinical evaluation at study start.

          -  Subject is currently using lithium or Plaquenil (hydroxychloroquine).

          -  Subject is currently using a beta-blocking medication (e.g., propanolol) or
             angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized.

          -  Subject is pregnant, lactating, or is planning to become pregnant during the study.

          -  Subject is currently enrolled in an investigational drug or device study.

          -  Subject has used an investigational drug or investigational device treatment within 30
             days prior to study start.

          -  Subject has been previously enrolled in this study and treated with a test article.