The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Calcipotriene Foam; Vehicle Foam
Intervention description: Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group; Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
Intervention MeSH terms: Calcipotriene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 363.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Plaque Psoriasis; Psoriasis

Summary:

      The purpose of this study is to determine the safety and effectiveness in the treatment of
      psoriasis on the scalp and on the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of understanding and willing to provide signed and dated written voluntary
             informed consent (and any local or national authorization requirements) before any
             protocol-specific procedures are performed.

          -  Male or female subjects at least 12 years old and in good general health.

          -  Able to complete the study and to comply with study instructions.

          -  Moderate plaque-type psoriasis on the body (excluding the scalp and face) defined as:

               -  Plaque-type psoriasis involving 3% to 10% of total body surface area (BSA).

               -  An Investigator's Static Global Assessment (ISGA) score of 3 at Baseline.

               -  Identification of a target lesion (>2 cm²) on the trunk or extremities with a
                  score of 2 or 3 (0-5 scale) for erythema, scaling and plaque thickness. Lesions
                  on the palms/soles, knees, elbow, and intertriginous areas should not be used as
                  the target lesion site.

          -  Involvement of at least 10% of the total scalp surface area with clinical signs
             (erythema, thickness, and scaliness) rated as moderate (3) based on the ISGA.

          -  Negative urine pregnancy test for females of childbearing potential. • Sexually active
             females of childbearing potential participating in the study must agree to use a
             medically acceptable method of contraception while receiving protocol-assigned
             product. A woman of childbearing potential is defined as one who is biologically
             capable of becoming pregnant; including perimenopausal women who are fewer than 2
             years from their last menses.

        Exclusion Criteria:

          -  Any subject who has participated in any previous calcipotriene foam clinical.

          -  Female who is pregnant, trying to become pregnant, or breastfeeding.

          -  Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs;
             or to any component of the investigational formulations.

          -  History of hypercalcemia or of vitamin D toxicity.

          -  Other serious skin disorder or any chronic medical condition that is not
             well-controlled.

          -  Use of nonbiologic systemic anti-psoriatic therapy (eg, corticosteroids, psoralen
             combined with exposure to ultraviolet light A [PUVA], ultraviolet light B [UVB],
             retinoids, methotrexate, cyclosporine, other immunosuppressive agents) within 4 weeks
             prior to enrollment.

          -  Systemic treatment with biological therapies (marketed or not marketed) with a
             possible effect on psoriasis within 4 weeks (etanercept), 2 months (adalimumab,
             alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (whichever is
             longer) for experimental products prior to randomization.

          -  Use of topical therapies that have a known beneficial effect on psoriasis, including
             but not limited to corticosteroids, retinoids, Vitamin D derivatives, coal tar, or
             anthralin, within 2 weeks prior to enrollment.

          -  Systemic medications for other medical conditions that are known to affect psoriasis
             (eg, lithium, beta adrenergic blockers) within 4 weeks prior to enrollment.

          -  Use of any investigational product within 4 weeks prior to enrollment, currently
             participating in another clinical trial, or plans to receive an investigational
             product during the study.

          -  Current drug or alcohol abuse (drug screening not required).

          -  Has a history of any immuno-compromizing disease.

          -  Any other condition that, in the judgment of the investigator, would put the subject
             at unacceptable risk for participation in the study.

          -  Employees of the investigator; study center; or Stiefel, a GSK company involved in the
             study; or an immediate family member (eg, partner, offspring, parents, siblings or
             sibling's offspring) of an employee involved in the study.