Study for Treatment With Calcipotriol/Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris

Exclusion Criteria

• •1. Body surface area (BSA) \> 10 % or Psoriasis Area and Severity Index (PASI) \> 10 at baseline
• •\* The palm of one hand is approximately 1 percent of the body surface area
• •2. Subjects with unstable forms of psoriasis including guttate, erythrodermic, exfoliative and pustular psoriasis, or psoriatic arthritis
• •3. Subjects with known disorders of calcium metabolism/hypercalcemia
• •4. Subjects with hypersensitivity to the active substances or to any of the excipients of the investigational products
• •5. Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within the following time periods prior to baseline visit
• •* etanercept - within 4 weeks prior to baseline
• •* adalimumab, alefacept, infliximab - within 2 months prior to baseline
• •* ustekinumab - within 4 months prior to baseline
• •* investigational product - within 4 weeks/5 half-lives (whichever is longer) prior to baseline
• •6. Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, cyclosporine and other immunosuppressants) within 4 weeks prior to baseline visit
• •7. Phototherapy within the following time periods prior to baseline visit
• •* PUVA or Grenz ray - within 4 weeks
• •* UV-B - within 2 weeks
• •8. Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to baseline visit
• •9. Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with class 1- 5 corticosteroids or vitamin D analogues within 2 weeks prior to baseline visit
• •10. Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with class 1-5 corticosteroids, vitamin D analogues within 2 weeks prior to baseline visit
• •11. Subjects with severe renal insufficiency
• •12. Subjects with severe hepatic disorders
• •13. Subjects with a confounding skin condition or disorders against psoriasis evaluation
• •14. Subjects with viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections on the treatment area
• •15. Subjects with skin manifestations in relation to tuberculosis or syphilis on the treatment area
• •16. Subjects with perioral dermatitis, atrophic skin, striae atrophicae on the treatment area
• •17. Subjects with fragility of skin veins, ichthyosis on the treatment area
• •18. Subjects with acne vulgaris, rosacea, wounds, ulcers, perianal and genital pruritus on the treatment area
• •19. Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors) during the study
• •20. Pregnant or lactating female subjects
• •21. Subjects who are planning a pregnancy during the entire study period