Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris

A Randomised, Double-blind, Active-controlled, Parallel, Multi-center Study to Investigate the Efficacy and Safety of Daivobet® Ointment in Patients With Psoriasis Vulgaris

This study will evaluate the efficacy and safety of calcipotriol plus betamethasone dipropionate ointment compared with calcipotriol ointment in the treatment of patients with psoriasis vulgaris for a duration of 4 weeks. The study will focus on the percentage change of the psoriasis area and severity index (PASI) from baseline to the end of week 4.

Inclusion Criteria:

• Clinical diagnosis of psoriasis vulgaris in a stable condition
• Extent of at least 10% of one or more body regions
• Amenable to topical therapy with maximum of 100 g/week of investigational product

Exclusion Criteria:

• Patients with more than 30% of body surface area involved
• Patients with facial psoriasis who need treatment
• Patients who need treatment of scalp psoriasis with WHO group IV topical corticosteroids, tretinoin or topical vitamin D derivatives
• Patients with unstable forms of psoriasis including guttate, erythrodermic, pustular, or arthritis psoriasis
• Systemic treatment of psoriasis with corticosteroids or other therapy
• Systemic antipsoriatic treatment (e.g. corticosteroids, immunosuppressive drugs, tretinoin, antibiotics, phototherapy or calcium agents) within 4 weeks prior to visit 1; or topical antipsoriatic treatment (e.g. keratolytics, topical corticosteroids, topical vitamin D derivatives, anthralin, crude coal tar, etc) within the previous 2 week period
• Patients with planned exposure to phototherapy that may affect the psoriasis during the study period