A Phase III Study in Subjects With Mild to Moderate Psoriasis.

Exclusion Criteria

• •1. Subject with history of hypersensitivity to betamethasone or calcipotriol or any component of the test or reference product or placebo.
• •2. Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
• •3. Subjects with diagnosis of mild to moderate psoriasis only in the scalp area.
• •4. Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis and seborrheic dermatitis).
• •5. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters.
• •6. Subject with history of psoriasis unresponsive to topical treatments.
• •7. Subject with psoriasis lesions predominantly on palms and soles or palmo-plantar area.
• •8. Subjects with the diagnosis pustulosis palmo-plantaris
• •9. Subject in need of systemic treatment
• •10. Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy.
• •11. Use of oral estrogen therapy, excluding oral contraceptive pills
• •12. Females who are pregnant, nursing, or planning a pregnancy
• •13. Females of childbearing potential who do not agree to utilize an adequate form of contraception.
• •14. Current significant medical problems that, in the discretion of the investigator, would put the subject at significant risk
• •15. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
• •16. Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
• •17. Current immunosuppression
• •18. Use of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept) within six months prior to Baseline.
• •19. Use of: 1) chemotherapy, or 2) radiation therapy, within three months prior to Baseline.
• •20. Use of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) oral retinoids, within two months prior to Baseline.
• •21. Use of: 1) systemic steroids, 2) systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) PUVA therapy, 5) UVB therapy, or 6) systemic anti-inflammatory agents, within one month prior to Baseline.
• •22. Use of: 1) topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriol, tazarotene), 2) topical corticosteroids, or 3) topical retinoids, within 2 weeks prior to Baseline.
• •23. Use of medicated shampoos with possible effect on psoriasis
• •24. Subject with positive serology tests like HIV, HCV \& HBsAg.