Calcipotriol cream with or without concurrent topical corticosteroid in psoriasis: tolerability and efficacy

Abstract

The objectives of the study were to determine whether concurrent treatment with calcipotriol (50 microg/g) and either clobetasone 17-butyrate cream (0.5 mg/g) (moderate potency) or betamethasone 17-valerate cream (1 mg/g) (potent) or placebo (vehicle of calcipotriol) was more effective and/or caused less skin irritation than calcipotriol cream (50 microg/g) used twice daily. It was a multicentre, double-blind, parallel group study. Patients applied calcipotriol cream in the morning and either vehicle (n = 174), calcipotriol (n = 174), clobetasone (n = 175) or betamethasone creams (n = 176) in the evening for up to 8 weeks. Adverse events led to withdrawal in 20 patients (2.9%). The mean percentage change in PASI (psoriasis area and severity index) was -40.6 in the calcipotriol/vehicle group, -48.3 in the calcipotriol/calcipotriol group, -53.7 in the calcipotriol/clobetasone 17-butyrate group and -57.5 in the calcipotriol/betamethasone 17-valerate group. A statistically significant difference was seen between the four treatment groups (P = 0.006) with calcipotriol/vehicle being less effective than the other treatments. A statistically significant difference in favour of calcipotriol/betamethasone 17-valerate was seen between the calcipotriol/calcipotriol group and the calcipotriol/betamethasone 17-valerate group. The majority of adverse events were skin irritations, which were reported for 31.2% of patients treated with calcipotriol/vehicle, 34.3% of patients treated with calcipotriol twice daily and 23.8% vs. 17.1% of patients treated with calcipotriol/clobetasone 17-butyrate and calcipotriol/betamethasone 17-valerate, respectively. Skin irritation was seen statistically significantly less frequently in patients treated with calcipotriol/ clobetasone 17-butyrate or calcipotriol/betamethasone 17-valerate (P = 0.001), whereas no difference was seen between the other groups. In conclusion, calcipotriol applied twice daily was as effective as calcipotriol/clobetasone 17-butyrate, but slightly less effective than calcipotriol/betamethasone 17-valerate. The incidence of skin irritation was less for patients using concurrent corticosteroids, whereas treatment with calcipotriol/vehicle did not reduce the incidence of skin irritation when compared with calcipotriol twice daily.

Stability Indicating RP-HPLC Method for Estimation of Impurities of Vitamin D<sub>3</sub> Analogue and Corticosteroid Used as Antipsoriatic Drugs. An Attempt to Characterize Pre-Calcipotriene

“…BD is believed to have anti-inflammatory and anti-pruritic actions that are characteristic of corticosteroids. Several studies have shown that combined therapy with products containing these two active substances is more effective than mono therapy, the additive clinical effects and reduced skin irritationmay be achieved [7]- [10].…”

Treatment of Psoriasis Vulgaris with Calcipotriol Betamethasone Dipropionate Combination Followed by Calcipotriol and Assessment of the Adjuvant Basic Use of Urea-Based Emollients

“…Treatment with the combination ointment gives relevant advantages also in terms of patient's compliance, thanks to the once-daily application, quality oflife parameters and tolerability profile (5-10). The use of combination product may reduce the risk of adverse events associated with the long-term use of corticosteroid monotherapy (atrophy and rebound) as well as the irritation associated with calcipotriol (18,21,22).…”

Safety and Efficacy of Combined High-Dose Treatment with Calcipotriol Ointment and Solution in Patients with Psoriasis

“…Since then, its therapeutic efficacy and safety in the treatment of psoriasis vulgaris have been demonstrated in several clinical trials evaluating the drug as either single-drug therapy or in combination with UVB, PUVA, cyclosporin, acitretin or topical corticosteroids [2, 3, 4, 5, 6]. In most trials, the applied amounts of calcipotriol ointment or cream (both 50 µg/g) have been considerably below the recommended dose maximum of 100 g/week.…”