A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis
Condition: Chronic Stable Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DFD06-Cream; Vehicle Cream
Intervention description: Twice daily topical application for 14 days.; Twice daily topical application for 14 days.
Intervention MeSH terms: Clobetasol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical
      treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject understands the study procedures and agrees to participate by giving written
             informed consent. Subjects must be willing to authorize use and disclosure of
             protected health information collected for the study.

          2. Subject must be at least 18 years of age.

          3. Subject must present with a clinical diagnosis of stable (at least 3 months)
             plaque-type psoriasis.

          4. Subject with psoriasis involving 3% or greater BSA, not including the face, scalp,
             groin, axillae and other intertriginous areas.

          5. Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.

          6. Female subjects of childbearing potential must agree to use contraception during the
             study which can include abstinence with an adequate secondary option should the
             subject become sexually active. All women of childbearing potential must complete a
             urine pregnancy test (test must have a sensitivity of at least 25mIU/ml for human
             chorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must be
             negative to be eligible for enrollment.

          7. Subject 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, or pigmented lesions or sunburn which
             could interfere with the rating of efficacy parameters.

          4. History of psoriasis unresponsive to biological or 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, secukinumab, or alefacept).

          7. Have received treatment for any type of cancer within 5 years of the Baseline Visit
             except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before
             the Baseline Visit.

          8. Use within 60 days prior to the Baseline Visit of: 1) systemic or topical
             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. 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 who have participated in a study of an investigational drug 60 days prior to
             the Baseline Visit.