Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone in the treatment of psoriasis vulgaris: a randomised, parallel group, double-blind, exploratory study

被引:63
作者
Fleming, Colin [2 ]
Ganslandt, Cecilia [1 ]
Guenther, Lyn [3 ]
Johannesson, Anders [4 ]
Buckley, Colin [5 ]
Simon, Jan C. [6 ]
Stegmann, Helen [1 ]
Tingleff, Lotte Vestergaard [1 ]
机构
[1] LEO Pharma AS, DK-2750 Ballerup, Denmark
[2] Univ Dundee, Ninewells Hosp & Med Sch, Dundee DD1 9SY, Scotland
[3] Guenther Dermatol Res Ctr, London, ON, Canada
[4] Vallingby Lakarhus, Vallingby, Sweden
[5] Waterford Reg Hosp, Waterford, Ireland
[6] Univ Klinikum Leipzig, Klin Dermatol Venerol & Allergol, Leipzig, Germany
关键词
betamethasone dipropionate; calcipotriol; combination therapy; psoriasis vulgaris; ONCE-DAILY TREATMENT; SCALP PSORIASIS; FORMULATION; EFFICACY; SAFETY; COMBINATION; POPULATION; TRIAL; ONSET;
D O I
10.1684/ejd.2010.0948
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
A two-compound ointment containing calcipotriol plus betamethasone dipropionate is an effective treatment for psoriasis vulgaris. The same active ingredients have now been combined in a gel formulation. Our objective was to compare the efficacy and safety of once daily treatment of the two-compound gel with the single components in the same gel vehicle and the gel vehicle alone, in patients with psoriasis vulgaris on the trunk and/or limbs. 364 patients received once daily treatment for up to 8 weeks with either the two-compound gel, the single components in the gel vehicle or the gel vehicle alone. The percentage of patients whose disease was clear or very mild and who had at least a two-step improvement in the Investigator's Global Assessment of disease severity at week 8, was significantly higher with calcipotriol plus betamethasone dipropionate (27.2%) than with betamethasone dipropionate (16.9%, p = 0.027), calcipotriol (11.4%, p = 0.006) or gel vehicle (0.0%, p < 0.001). This exploratory study showed that the two-compound gel was safe and more efficacious than its individual ingredients in the treatment of psoriasis vulgaris.
引用
收藏
页码:465 / 471
页数:7
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