Conditions: Psoriasis Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1245
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190) arm 2: Ointment Vehicle arm 3: Calcipotriol 25 mcg/g in the ointment vehicle arm 4: Hydrocortisone 10 mg/g in the ointment vehicle

Interventions: intervention 1: Calcipotriol plus hydrocortisone (LEO 80190) intervention 2: LEO 80190 Vehicle intervention 3: Hydrocortisone intervention 4: Calcipotriol
Intervention descriptions: intervention 1: Once daily application intervention 2: None intervention 3: None intervention 4: None

Protocol document: