The long-term safety and effectiveness of calcipotriene 0.005% ointmen
t has been evaluated in the treatment of 397 patients with stable plaq
ue psoriasis. In this multicenter, open-label clinical investigation,
the psoriasis characteristics of scaling, erythema, and plaque elevati
on and overall disease severity were evaluated periodically. Patients
were carefully questioned and observed at each visit for adverse event
s. Laboratory parameters for safety were also evaluated at regular int
ervals. At the end of the study, 235 subjects were considered assessab
le. Psoriatic plaques were cleared by week 8 in 25% of the subjects. T
he 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four subjects were prematurely withdrawn from the study due to adverse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 s
tudy showed that calcipotriene 0.005% ointment is safe and effective f
or long-term use in the treatment of plaque psoriasis.