NCT01422434

LEO 90105 Ointment in Japanese Subjects With Psoriasis

Efficacy and Safety of LEO 90105 Ointment (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 676 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	LEO 90105 = calcipotriol + betamethasone dipropionate	Applied once daily for 4 weeks.
DRUG	Dovonex® = calcipotriol	Applied twice daily for 4 weeks.
DRUG	Rinderon® - DP = betamethasone dipropionate	Applied once daily for 4 weeks.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-08-24
• Last updated: 2025-03-12
• Results posted: 2014-03-11

Locations

1 site across 1 country: Japan