NCT01188928

LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

A Phase 3 Study Comparing Once Daily Treatment With Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension With Betamethasone 0.5 mg/g (as Dipropionate) in the Topical Suspension Vehicle, Calcipotriol 50 mcg/g in the Topical Suspension Vehicle and the Topical Suspension Vehicle Alone in Subjects With Psoriasis Vulgaris on Non-scalp Regions of the Body (Trunk and/or Limbs)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,152 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Calcipotriol plus betamethasone	Topical suspension once daily for up to 8 weeks.
DRUG	Betamethasone-17,21-dipropionate	Topical suspension once daily for up to 8 weeks.
DRUG	Calcipotriene	Topical suspension once daily for up to 8 weeks.
DRUG	Topical suspension vehicle	Topical suspension once daily for up to 8 weeks.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-08-26
• Last updated: 2025-03-10
• Results posted: 2013-04-09

Locations

59 sites across 1 country: United States