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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
782
Once daily application for up to 8 weeks
Once daily application for up to 8 weeks
Once daily application for up to 8 weeks
Probity Medical Research
Waterloo, Ontario, Canada
Hôpital de l'Archet
Nice, France
Ninewells Hospital & Medical School
Dundee, United Kingdom
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8
Time frame: Week 8
Overall Disease Severity of the Face According to the Investigator's Assessment
Time frame: Week 4
Total Sign Score of the Face
Time frame: Week 8
Severity Scores for Redness, Thickness and Scaliness of the Face
Time frame: Week 8
Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment
Time frame: Week 8
Total Sign Score of the Intertriginous Areas
Time frame: Week 8
Patients With Relapse During the Study and Time to Relapse
Time frame: Week 8-16
Patients With Rebound During the Study
Time frame: Week 8-16
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