COMPARATIVE EFFICACY OF CALCIPOTRIOL (MC903) CREAM AND BETAMETHASONE 17-VALERATE CREAM IN THE TREATMENT OF CHRONIC PLAQUE PSORIASIS - A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP MULTICENTER STUDY

The efficacy, safety and tolerability of calcipotriol cream was compar ed with betamethasone 17-valerate cream in the treatment of plaque-typ e psoriasis in a multicentre double-blind, parallel group study, Patie nts with stable mild-to-moderate chronic disease were randomized to tr eatment with either calcipotriol, 50 mu g/g, in a cream formulation (2 10 patients) or betamethasone 17-valerate cream, 1 mg/g (211 patients) , After a wash-out period of 2 weeks, the treatment was applied twice daily, without occlusion, for 8 weeks or to complete clearing. The sev erity of psoriasis was assessed using the PASI at baseline and after 4 and 8 weeks treatment, The mean percentage reduction of PASI from bas eline to end of treatment was 47.8% in the calcipotriol group and 45.4 % in the betamethasone group. The reduction from baseline was highly s ignificant in both groups, but the difference between the groups was n ot significant. There was a difference in the reduction in thickness o f the lesions in favour of calcipotriol. The investigator's as well as the patient's overall assessment of treatment response at end of trea tment showed no difference between the two treatment groups. Treatment -related adverse events were more frequent with calcipotriol than beta methasone. Lesional/perilesional irritation was reported in 16% and 9% (P = 0.03), and facial irritation in 10% and 0.5% (P < 0.001), respec tively No change was found in serum levels of calcium. Calcipotriol in a cream formulation was effective, safe, well-tolerated, and equal in effect to betamethasone valerate cream.