Efficacy of an Innovative Aerosol Foam Formulation of Fixed Combination Calcipotriol plus Betamethasone Dipropionate in Patients with Psoriasis Vulgaris
Efficacy of an Innovative Aerosol Foam Formulation of Fixed Combination Calcipotriol plus Betamethasone Dipropionate in Patients with Psoriasis Vulgaris
复制标题
DOI：
10.1007/s40261-015-0269-7
复制
发表时间：
2015-04-01
影响因子：
3.2
通讯作者：
Lacour, Jean-Philippe
中科院分区：
文献类型：
--
作者：
Queille-Roussel, Catherine;Olesen, Martin;Lacour, Jean-Philippe
背景与目的探讨由钙三醇50 μ g/g（水合物；Cal）和倍他米松0.5 mg/g（二丙酸酯；BD）固定组合的创新气溶胶泡沫制剂的抗银屑病效果，并与一线治疗Cal/BD软膏的效果进行比较。方法：这是一项IIa期、单中心、研究者盲法、探索性研究，采用改良的银屑病斑块试验进行个体内比较。患者接受Cal/BD泡沫、Cal/BD软膏、BD泡沫和Cal/BD泡沫载体的治疗，每天1次（6天/周），持续4周，随机分配到4个斑块试验点（每个5厘米(2)）。主要疗效终点是临床总评分（TCS；红斑、结垢和病变厚度的总和）的变化。次要终点包括超声总皮肤厚度和回波差带厚度的变化，以及不良事件。结果24例患者完成了本研究，中位年龄52.5岁（21-75岁）。在第4周，与Cal/BD软膏（-5.25 +/- a 1.78；差值-0.75;95% CI -1.46至-0.04;p = 0.038）、BD泡沫（-4.96 +/- a 1.85；差值-1.04;95% CI -1.75至-0.33;p = 0.005）或泡沫载体（-1.88 +/- a 1.12；差值-4.13;95% CI -4.83至-3.42;p < 0.001）相比，Cal/BD泡沫处理的试验点的平均（+/- SD） TCS （-6.00 +/- a 1.27）显著降低。Cal/BD泡沫处理部位的皮肤总厚度和回波差带厚度比比较物处理部位的皮肤总厚度和回波差带厚度减少的程度更大。11例患者报告了17个不良事件，最常见的是头痛（5例）。没有病变/病变周围不良事件或药物相关不良事件。结论Cal/BD泡沫的抗银屑病效果明显优于单独使用Cal/BD软膏、BD泡沫和泡沫载体。
Background and Objective The antipsoriatic effect of an innovative aerosol foam formulation of fixed combination calcipotriol 50 mu g/g (as hydrate; Cal) and betamethasone 0.5 mg/g (as dipropionate; BD) was explored in order to compare the effect with that of the first-line treatment Cal/BD ointment.Methods This was a Phase IIa, single-centre, investigator-blinded, exploratory study, with intra-individual comparison using a modified psoriasis plaque test. Patients were treated once daily (6 days/week) for 4 weeks with Cal/BD foam, Cal/BD ointment, BD foam and Cal/BD foam vehicle, randomized to four plaque test sites (5 cm(2) each). The primary efficacy endpoint was change in total clinical score (TCS; sum of erythema, scaling and lesional thickness). Secondary endpoints included ultrasonographic changes in total skin thickness and echo-poor band thickness, and adverse events.Results Twenty-four patients, median age 52.5 years (range 21-75), completed this study. At week 4, test sites treated with Cal/BD foam had a significantly greater decrease in mean (+/- SD) TCS (-6.00 +/- A 1.27) versus those treated with Cal/BD ointment (-5.25 +/- A 1.78; difference -0.75; 95 % CI -1.46 to -0.04; p = 0.038), BD foam (-4.96 +/- A 1.85; difference -1.04; 95 % CI -1.75 to -0.33; p = 0.005) or foam vehicle (-1.88 +/- A 1.12; difference -4.13; 95 % CI -4.83 to -3.42; p < 0.001). Total skin thickness and echo-poor band thickness of Cal/BD foam-treated sites were reduced to a greater extent than those treated with comparators. Eleven patients reported 17 adverse events, the most frequent being headache (five patients). There were no lesional/perilesional adverse events or adverse drug-related events.Conclusions Cal/BD foam demonstrated a significant improvement in antipsoriatic effect over Cal/BD ointment, BD foam and foam vehicle alone.