Comparative efficacy of calcipotriol (MC903) cream and betamethasone 17-valerate cream in the treatment of chronic plaque psoriasis. A randomized, double-blind, parallel group multicentre study

Abstract

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.

Clobetasol propionate shampoo 0.05% and calcipotriol solution 0.005%: A randomized comparison of efficacy and safety in subjects with scalp psoriasis

“…The finding of a burning sensation with calcipotriol is consistent with the known adverse effect profile of that treatment. Other studies with calcipotriol have shown that irritation of the scalp and face is a common side effect of calcipotriol treatment in subjects with scalp psoriasis, and is significantly more common than that seen during steroid treatment [15,[19][20][21].…”

Cost-Effectiveness Model of Topical Treatment of Mild to Moderate Psoriasis Vulgaris in Germany

“…The efficacy is as high as moderately potent steroids [4, 9]. The combination of calcipotriol with steroids further increases the effectiveness of the therapy, due to synergistic effects of the drugs [11,12,13,14,15]. The once daily application of calcipotriol and betamethasone dipropionate as a 2-compound product could offer an even higher effectiveness and cost-effectiveness compared to a twice daily application of the respective compounds, due to a higher compliance, enhanced synergistic effects and lower treatment costs.…”

“…Betamethasone dipropionate, a group III corticosteroid, acts via a glucocorticoid receptor and suppresses inflammation and hyperproliferation [10]. Several studies have shown that the combination of these 2 reagents has synergistic or additive effects and is better tolerated than either monotherapy [11,12,13,14,15]. In addition, the long-term safety of a fix calcipotriol/betamethasone dipropionate combination (Daivobet®/Dovobet®/Taclonex®) has been evaluated positively in several studies [16,17,18,19].…”

Mechanisms of action of topical therapies and the rationale for combination therapy

“…Several studies have examined the concomitant or sequential use of topical corticosteroids with vitamin D analogs for the treatment of patients and demonstrated this combination was safe, effective, and reduced the irritation associated with at least one analog, calicipotriene. [41][42][43][44][45][46][47][48][49][50] In one multicenter, double-blind study, calcipotriene was applied in the morning and halobetasol ointment in the evening, resulting in a reduced overall severity of psoriasis versus monotherapy. 51 Another study used a similar regimen for 2 weeks and then switched patients to pulse therapy, consisting of halobetasol ointment twice daily on weekends and calcipotriene ointment twice daily on weekdays.…”