Conditions: Psoriasis Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1152
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).

Detailed description:

Arms:
arm 1: Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension arm 2: Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle arm 3: Calcipotriol 50 mcg/g in the topical suspension vehicle arm 4: The topical suspension vehicle alone

Interventions: intervention 1: Calcipotriol plus betamethasone intervention 2: Betamethasone-17,21-dipropionate intervention 3: Calcipotriene intervention 4: Topical suspension vehicle
Intervention descriptions: intervention 1: Topical suspension once daily for up to 8 weeks. intervention 2: Topical suspension once daily for up to 8 weeks. intervention 3: Topical suspension once daily for up to 8 weeks. intervention 4: Topical suspension once daily for up to 8 weeks.

Protocol document: