Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Taclonex
Intervention description: Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).
Intervention MeSH terms: Calcitriol; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: plaque psoriasis; taclonex; crossover

Summary:

      This is an open label, investigator-blinded, cross over, prospective, single center study of
      subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone
      dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone
      dipropionate 0.064%) Topical Suspension will each be applied topically once daily.

      The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005%
      and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene
      0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female, age 18 or older, in good health.

          -  Subject has plaque-type psoriasis- no history of or current pustular, erythrodermic or
             guttate psoriasis.

          -  Subject is capable of understanding and willing to provide a signed and dated written
             voluntary informed consent before any protocol specific procedures are performed.

          -  The percentage of overall body surface involvement is between 1-10% on the trunk or
             extremities and is amenable to topical treatment with less than 100g of topical
             medication per week.

          -  The subject has an investigator global assessment of mild to moderate plaque psoriasis
             (severity index between 2 and 3 on a 5 point scale).

          -  The subject is able to complete the study and comply with study instructions,
             including attending all study visits.

          -  If a female subject of childbearing potential, subject has a negative urine pregnancy
             test. Sexually active women of childbearing potential participating in the study must
             have been using a medically acceptable form of contraception (which includes barrier
             methods, oral contraception, injectable or implantable methods, or intrauterine
             devices) for at least three months prior to entry into the study. A woman of
             childbearing potential is defined as one who is biologically capable of becoming
             pregnant. Abstinence is considered an acceptable method of contraception.

        Exclusion Criteria:

          -  Subject has used experimental drugs or devices at least one month prior to Baseline.

          -  Subject has used systemic corticosteroid, phototherapy, retinoids, methotrexate,
             cyclosporine, or other immunosuppressive agents or biologics therapy (ie, alefacept,
             etanercept, efalizumab) within four weeks of Baseline.

          -  Subject has used topical therapy, corticosteroid therapy, topical vitamin D analog or
             calcineurin inhibitors or , tazarotene within two weeks prior to the Baseline visit
             (eg, tar, anthralin, salicylic acid, lactic acid, urea preparations).

          -  Subject has other serious skin disorder or any chronic medical condition that is not
             well controlled.

          -  Subject has clinically relevant abnormal vital signs or findings on the physical
             examination.

          -  Subject has major illness within 30 days prior to the Baseline visit.

          -  Subject has history of any immunocompromising disease.

          -  Subject is pregnant or nursing. Pregnant and nursing females will not be allowed in
             the study, and females of childbearing potential will have a pregnancy test at
             Baseline.

          -  Subject has a skin condition or disease that may require concurrent therapy or may
             confound the evaluation; a history of hypersensitivity to any of the formulation
             components; or atopic dermatitis.