NCT00216827

Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis

Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,485 (planned)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis. The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.

Conditions

• Psoriasis of Scalp

Interventions

Type	Name	Description
DRUG	Calcipotriol plus betamethasone dipropionate (LEO80185 gel)

Timeline

• Start date: 2004-11-01
• Completion: 2005-09-01
• First posted: 2005-09-22
• Last updated: 2025-02-24

Locations

8 sites across 8 countries: Canada, Denmark, France, Norway, Portugal, Spain, Sweden, United Kingdom