Conditions: Psoriasis
Keywords: A national multi-centre prospective randomised double-blind active-controlled 3-arm parallel group 4 week study
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 676
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once daily with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily in Japanese subjects with psoriasis vulgaris.

Detailed description:
LEO 90105 ointment contains both calcipotriol and betamethasone dipropionate. It has been approved for the treatment of psoriasis in more than 60 centres, including most European countries, the US, China, Korea and Taiwan. This trial will investigate its safety and efficacy in the treatment of Japanese subjects with psoriasis.

Arms:
arm 1: LEO 90105 ointment applied once daily for 4 weeks. arm 2: Applied twice daily for 4 weeks. arm 3: Applied once daily for 4 weeks

Interventions: intervention 1: LEO 90105 = calcipotriol + betamethasone dipropionate intervention 2: Dovonex® = calcipotriol intervention 3: Rinderon® - DP = betamethasone dipropionate
Intervention descriptions: intervention 1: Applied once daily for 4 weeks. intervention 2: Applied twice daily for 4 weeks. intervention 3: Applied once daily for 4 weeks.

Protocol document: