TACALCITOL OINTMENT IN THE TREATMENT OF PSORIASIS-VULGARIS - A MULTICENTER, PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY ON EFFICACY AND SAFETY

Tacalcitol is a vitamin D analogue which has been developed for the th erapy of psoriasis vulgaris. The treatment with a twice daily applicat ion of 2 mu g/g ointment is efficacious and safe in Japanese patients, The objective of this randomized, placebo-controlled, intraindividual right-left comparison was to investigate the efficacy and safety of 8 weeks' therapy with a once daily application of a 4 mu g/g tacalcitol ointment in Caucasian psoriatics. The data on 122 male and female pat ients were analysed. The score sum of erythema, infiltration and desqu amation was influenced significantly more by tacalcitol ointment than by placebo (P < 0.0001) at every control point, starting from week 2. With regard to the individual symptoms of desquamation, infiltration a nd erythema, the treatment with tacalcitol was also superior to placeb o treatment beginning at week 2, Qualitatively, the same results were obtained with the preference assessment of both treated body sides and also the global assessments of efficacy and benefit. Symptoms of loca l skin irritation which may be related to the active compound or the o intment base were reported by 12.3% of patients. In only one patient, irritation required discontinuation of tacalcitol treatment, Laborator y criteria, including serum calcium, serum phosphate and serum levels of calcitonin, parathormone, 1 alpha,24-dihydroxyvitamin D-3 and 25-hy droxyvitamin D-3, did not reveal any changes of clinical relevance dur ing or after treatment, Furthermore, the global assessment of toleranc e was good or very good in more than 90% of cases. The results of this study demonstrate that the once daily application of a 4 mu g/g tacal citol ointment is an efficacious therapy for psoriasis vulgaris in Cau casian patients, and that its tolerance is good, wherever the lesion i s located, including on the face.