Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis

Exclusion Criteria

• •1. Erythrodermic Ps, medication-induced or medication-exacerbated Ps or new onset guttate Ps or other skin conditions at the time of the screening visit (e.g. eczema) that would interfere with evaluations of the effect of the investigational product on Ps;
• •2. Use of any anti-psoriatic therapy last administered less than 4 weeks of start of study drug such as
• •1. Three months or 5 PK half-lives, whichever is longer, for biologics tumor necrosis factor (TNF) antagonists, interleukin (IL) 12/23/17 inhibitors or other biologic drugs
• •2. 4 weeks for immunosuppressive / -modulating drugs including cyclosporine A, methotrexate, azathioprine, mycophenolate mofetil, fumaric acid esters, retinoids, JAK inhibitors, corticosteroids, any other experimental drug, etc.
• •3. Topical medications (eg. Corticosteroids) except coal tar shampoo, and/or salicylic acid scalp preparations on scalp lesions.
• •4. 4 weeks for phototherapy (ie, UVB, PUVA).
• •3. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit;
• •4. Positive serology for hepatitis B, hepatitis C, HIV indicating acute or chronic infection;
• •5. Chronic recurring bacterial infections or active TB;
• •6. Positive pregnancy test at Screening or at the Baseline visit;
• •7. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
• •8. History of clinically significant alcohol or drug abuse in the last 12 months;
• •9. Known hypersensitivity to the excipients of Otezla® as stated in the label;
• •10. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
• •11. Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.