A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Taclonex Topical Suspension
Intervention description: topical medication for psoriasis
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; Taclonex; Acitretin; Methotrexate

Summary:

      Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective
      when used as monotherapy (without other oral medicines or creams) than are newer biologic
      injected drugs. However, these oral medications are also less expensive than biologic agents
      and may be safer for use in some patients. The purpose of this study is to determine if
      adding a topical psoriasis medicine, calcipotriene/betamethasone topical suspension (Taclonex
      topical suspension), will improve the severity of psoriasis in patients already on
      methotrexate or acitretin and to determine if adding this topical suspension will reduce the
      desire of such patients to switch to a biologic agent to treat their psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects age 18 years and older with stable plaque psoriasis of duration of at least 6
             months.

          -  Subject must be currently using a stable dose, with stable disease severity, of a
             single non-biologic systemic psoriasis medication (methotrexate or acitretin) for at
             least 2 months.

          -  Subject must be planning to continue current systemic agent, and standard of care
             monitoring for that medication

          -  All labs required for methotrexate or acitretin will be done according to standard of
             care.

          -  If a woman, before entry she must be: Postmenopausal, or practicing a highly effective
             method of birth control

          -  Women of childbearing potential must have a negative urine pregnancy test prior to
             randomization

          -  Subject must be able and willing to provide written informed consent to participate.

        Exclusion Criteria:

          -  Non-plaque psoriasis (pustular, erythrodermic, or guttate).

          -  Use of excluded therapies: phototherapy use currently or in the 4 weeks prior to
             baseline, use of more than 1 systemic therapy in the 2 months prior to baseline, use
             of topical steroid, tar preparation, or vitamin D analog in the 4 weeks prior to
             baseline.

          -  Subjects who are currently taking or have taken in the past 60 days, for any reason,
             any medication that, in the opinion of the investigator, suppressed the immune
             response. This may include but is not limited to systemic steroids, azathioprine,
             cyclosporine, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab,
             infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or
             cytokine in the immune system.

          -  Subjects with any use at any time in the past of Taclonex topical suspension or
             Taclonex ointment

          -  Subjects who are pregnant, nursing, or plan on becoming pregnant during the course of
             the study.

          -  Presence of any unstable medical or psychiatric condition that, in the opinion of the
             investigator, could impair subject compliance.

          -  Subject has any active infection within 30 days prior to baseline.

          -  Known or suspected disorders of calcium metabolism

          -  Known or suspected severe kidney or liver disease.

          -  Known or suspected hypersensitivity to component(s) of the investigational products.