Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen; Clobex® Spray morning and Vectical™ Ointment evening regimen
Intervention description: Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days; Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days
Intervention MeSH terms: Calcitriol; Clobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate)
      Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one
      of two different regimens:

        1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray
           treatment twice daily on weekends (Sat - Sun) for 28 days

        2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18 to 80 years inclusive

          -  Subjects with an Overall Disease Severity of 3 (moderate)

          -  Subjects with 3% - 10% treatable BSA (Body Surface Area) excluding scalp, face, groin,
             axillae and/or other intertriginous areas

          -  For concurrent medications, type and dose must have been stable for at least 3 months
             prior to study entry and not expected to change during the study. Subjects receiving
             treatment with beta-blockers or lithium, whose dose has been stable for at lest 6
             months and who have shown no worsening of their psoriasis, may be included in the
             study, at the discretion of the investigator

        Exclusion Criteria:

          -  Subjects with intakes of more than 2,000 IU/day (50 mcg/day) of vitamin D (tolerable
             upper intake level) and/or more than 1,000 mg/day of calcium

          -  Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other
             intertriginous areas

          -  Subjects with a wash-out period for topical treatment less than 30 days (Any steroid
             containing medication, dovonex, anthralin, tar and/or UVB treatment)

          -  Subjects with a wash-out period for systemic treatment less than 12 weeks
             (corticosteroids, biologics and/or PUVA treatment; Examples of these therapies
             include, but are not limited to PUVA, Soriatane, Cyclosporine, Hydroxyurea,
             Mycophenolate mofetil, Sulfasalazine, Azathioprine, Alefacept, Efalizumab, Adalimumab,
             Etanercept, Infliximab, Rituximab, and Methotrexate)

          -  Subjects with non-plaque psoriasis or other related diseases not classified as plaque
             psoriasis

          -  Subjects who foresee intensive UV exposure during the study (mountain sports, UV
             radiation, sunbathing, etc.)