Long-term effectiveness and safety of topical calcipotriene for psoriasis. Calcipotriene Study Group.

Abstract

The long-term safety and effectiveness of calcipotriene 0.005% ointment has been evaluated in the treatment of 397 patients with stable plaque psoriasis. In this multicenter, open-label clinical investigation, the psoriasis characteristics of scaling, erythema, and plaque elevation and overall disease severity were evaluated periodically. Patients were carefully questioned and observed at each visit for adverse events. Laboratory parameters for safety were also evaluated at regular intervals. At the end of the study, 235 subjects were considered assessable. Psoriatic plaques were cleared by week 8 in 25% of the subjects. The median time to initial clearing was between 16 and 17 weeks. Forty-four subjects were prematurely withdrawn from the study due to adverse events, which were considered related to treatment in only 28. This study showed that calcipotriene 0.005% ointment is safe and effective for long-term use in the treatment of plaque psoriasis.