NCT00640822

Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds

A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intertriginous Areas

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 782 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Calcipotriol plus hydrocortisone ointment vehicle	Once daily application for up to 8 weeks
DRUG	Tacalcitol Ointment	Once daily application for up to 8 weeks
DRUG	Calcipotriol plus hydrocortisone ointment	Once daily application for up to 8 weeks

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2008-03-21
• Last updated: 2025-03-07
• Results posted: 2010-12-21

Locations

3 sites across 3 countries: Canada, France, United Kingdom