NCT00691002

Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,245 (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 calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the safety and efficacy will be evaluated for up to 60 weeks treatment as required of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face and intertriginous areas (= open-label phase).

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Calcipotriol plus hydrocortisone (LEO 80190)	Once daily application
DRUG	LEO 80190 Vehicle
DRUG	Hydrocortisone
DRUG	Calcipotriol

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-06-05
• Last updated: 2025-03-10
• Results posted: 2021-08-26

Locations

11 sites across 4 countries: Croatia, Germany, Poland, Serbia