DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis

Exclusion Criteria

• •1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
• •2. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
• •3. Have received treatment for any type of cancer within 5 years of the Baseline Visit.
• •4. 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) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
• •5. 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.
• •6. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
• •7. Subjects who have an abnormal sleep schedule or work overnight.
• •8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
• •9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.