DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

Inclusion Criteria

• Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
• Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
• Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit
• Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA function or adrenal response. -

Exclusion Criteria

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
• History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
• 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.
• Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea)
• Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene)2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
• Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
• Subjects who have an abnormal sleep schedule or work at night.
• Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
• Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.