The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel. The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
800
Clinique de Dermatologie
Moncton, Canada
Hørsholm Hospital, Dermatological Department
Hørsholm, Denmark
Hôpital Nord, Service de Dermatologie
Saint-Etienne, France
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
Münster, Germany
The proportions of patients who experience adverse drug reactions and the proportion of patients who experience adverse events of concern associated with long-term topical corticosteroid use on the scalp during the study
Percentage of post-baseline satisfactorily controlled assessments according to the Investigators' Global Assessment of disease severity during the study
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Monklands Hospital, Department of Dermatology
Airdrie, United Kingdom