A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis

Inclusion Criteria:

1. Subject understands the study procedures and agrees to participate by giving writteninformed consent. Subjects must be willing to authorize use and disclosure ofprotected 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 thestudy which can include abstinence with an adequate secondary option should thesubject become sexually active. All women of childbearing potential must complete aurine pregnancy test (test must have a sensitivity of at least 25mIU/ml for humanchorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must benegative to be eligible for enrollment.

7. Subject must be in good general health as determined by the investigator and supportedby 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 plaquepsoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).

3. Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn whichcould 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 otherimmunocompromised 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 Visitexcept skin cancer and cervical cancer (in situ) are allowed if at least 1 year beforethe Baseline Visit.

8. Use within 60 days prior to the Baseline Visit of: 1) systemic or topicalimmunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatictreatment (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) PUVAtherapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil,sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasalsteroids 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 tothe Baseline Visit.