The purpose of the study is to evaluate whether once daily topical 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 and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis. The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,350
Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie
Leuven, Belgium
Innovaderm Research Inc.
Montreal, Quebec, Canada
Policlinic of Dermatology, Medical Reception Centre
Turku, Finland
Hôpital Trousseau, Service de Dermatologie CHU Tours
Tours, France
- Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
- Total sign score at week 8
- Score for scaliness, redness and thickness at week 8
- Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 2 and 4
- Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8
- Evaluation of Adverse Events
- Evaluation of Laboratory Data
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Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie
Göttingen, Germany
Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie
Nijmegen, Netherlands
Royal Gwent Hospital, Department of Dermatology
Newport, United Kingdom