Conditions: Psoriasis Vulgaris
Keywords: LEO 80185 gel, calcipotriol, betamethasone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 213
Healthy volunteers: no

Brief summary:
To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Detailed description:
A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 80185 gel versus Dovobet® ointment in Japanese subjects with psoriasis vulgaris.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: LEO 80185 gel intervention 2: Dovobet ® ointment
Intervention descriptions: intervention 1: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions intervention 2: calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions

Protocol document: