Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Cloderm Cream
Intervention MeSH terms: Clocortolone pivalate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Cloderm Cream is effective for topical
      treatment of moderate psoriasis over 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject understands the study procedures and agrees to participate by giving written
             informed consent.

          2. Subjects must be at least 18 years of age.

          3. Subjects must present with a clinical diagnosis of stable (at least 3 months)
             plaque-type psoriasis.

          4. Subjects with psoriasis involving 2 to 20% BSA, not including the face, scalp and
             intertriginous areas.

          5. Subjects must have an IGA Grade of 3 at the Baseline Visit.

          6. Female subjects of childbearing potential must have a negative urine pregnancy test
             result at Baseline (Visit 2) (test will have a sensitivity of at least 25mIU/ml for
             human chorionic gonadotropin) and practice a reliable method of contraception or
             remain sexually inactive throughout the study.

             All women of childbearing potential must be willing to undergo a urine pregnancy test
             at Visit 2 (Day 0), at Visit 4 (Day 14), and at Visit 5 (Day 28).

          7. Subjects must be in good general health as determined by the investigator and
             supported by the medical history and normal or not clinically significant abnormal
             vital signs (blood pressure and pulse).

        Exclusion Criteria:

          1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
             exfoliative or pustular psoriasis.

          2. Other inflammatory skin disease that may confound the evaluation of the plaque
             psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).

          3. Presence of pigmentation, extensive scarring, pigmented lesions or sunburn which could
             interfere with the rating of efficacy parameters.

          4. History of psoriasis unresponsive to topical treatments.

          5. History of organ transplant requiring immunosuppression, HIV, or other
             immunocompromised state.

          6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g.,
             infliximab, adalimumab, etanercept, ustekinumab, or alefacept).

          7. Have received treatment for any type of cancer within 5 years of the Baseline Visit
             except for non-melanoma skin cancer and cervical cancer (in situ) are allowed within 1
             year of the Baseline Visit.

          8. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g.,
             tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate,
             cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).

          9. Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA
             therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil,
             sulfasalazine, 6-thioguanine), or 4) UVB therapy. Note: Inhaled, intraocular and
             intranasal steroids are allowed.

         10. Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs
             (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids
             (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.

         11. Subjects with known hypersensitivity to clocortolone pivalate or any component of
             Cloderm Cream.

         12. Subjects who have participated in a study of an investigational drug 60 days prior to
             the Baseline Visit.

         13. Subjects unable to comply with study requirements.

         14. Female subjects who are pregnant (or planning to become pregnant) or breast-feeding.