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Calcipotriol cream with or without concurrent topical corticosteroid in psoriasis: tolerability and efficacy
Author(s) -
Kragballe,
Sean Barnes,
Hamberg,
; Murphy,
Møller,
Růzicka,
van de Dh Daan Kerkhof
Publication year - 1998
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1046/j.1365-2133.1998.02461.x
Subject(s) - calcipotriol , tolerability , medicine , dermatology , psoriasis , corticosteroid , surgery , adverse effect
The objectives of the study were to determine whether concurrent treatment with calcipotriol (50 μg/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 μg/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.