The efficacy, safety and tolerability of
calcipotriol cream was compared with
betamethasone 17-valerate cream in the treatment of plaque-type
psoriasis in a multicentre double-blind, parallel group study. Patients with stable mild-to-moderate
chronic disease were randomized to treatment with either
calcipotriol, 50 micrograms/g, in a cream formulation (210 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 severity of
psoriasis was assessed using the PASI at baseline and after 4 and 8 weeks treatment. The mean percentage reduction of PASI from baseline to end of treatment was 47.8% in the
calcipotriol group and 45.4% in the
betamethasone group. The reduction from baseline was highly significant in both groups, but the difference between the groups was not significant. There was a difference in the reduction in thickness of the lesions in favour of
calcipotriol. The investigator's as well as the patient's overall assessment of treatment response at end of treatment showed no difference between the two treatment groups. Treatment-related adverse events were more frequent with
calcipotriol than
betamethasone. Lesional/perilesional irritation was reported in 16% and 9% (P = 0.03), and facial irritation in 10% and 0.5% (P < 0.001), respectively. 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.