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以Dermacatch作为一种新的测量方法评估半胱胺乳膏治疗表皮型黄褐斑的疗效:一项随机双盲安慰剂对照研究。

Efficacy of cysteamine cream in the treatment of epidermal melasma, evaluating by Dermacatch as a new measurement method: a randomized double blind placebo controlled study.

作者信息

Farshi Susan, Mansouri Parvin, Kasraee Behrooz

机构信息

a Skin and Stem Cell Research Center , Tehran University of Medical Sciences , Tehran , Iran.

b Scientis Pharma SA , Geneva , Switzerland.

出版信息

J Dermatolog Treat. 2018 Mar;29(2):182-189. doi: 10.1080/09546634.2017.1351608. Epub 2017 Jul 26.

Abstract

BACKGROUND

Melasma is a difficult-to-treat hyperpigmentary disorder. Very few studies have been performed regarding the efficacy of cysteamine in the treatment of melasma.

OBJECTIVE

To determine the efficacy of cysteamine cream in the treatment of patients with epidermal melasma using Dermacatch as a more accurate skin colorimetric measurement tool.

METHODS

Participating patients (n = 40) received either placebo (n = 20) or cysteamine cream (n = 20) in a double-blind placebo controlled study. Cysteamine cream or placebo was applied on the lesions once a day at bedtime throughout the four-month study period. Treatment efficacy was determined through Dermacatch and Mexameter skin colorimetry, MASI scores, Investigator Global Assessments (IGAs), and patient questionnaires, all performed at baseline, 2-month, and 4-month examinations.

RESULTS

Prior to the start of the protocol, the mean difference between pigmented and normal skin was calculated for cysteamine and placebo groups using both Dermacatch (72.3 ± 27.8 and 52.9 ± 16.4, respectively) and Mexameter (93.6 ± 42.6 and 65.4 ± 22.6, respectively). At 2 months, the mean differences were 38.1 ± 15.3 (Dermacatch) and 49.9 ± 19 (Mexameter) in the cysteamine group and 64.9 ± 25.3 (Dermacatch) and 68 ± 26.2 (Mexameter) in the placebo group. At 4 months, the mean differences were 23.8 ± 12.9 (Dermacatch) and 35.5 ± 16.1 (Mexameter) in the cysteamine group, and 50 ± 18 (Dermacatch) and 51.2 ± 16.8 (Mexameter) in the placebo group. Statistically significant differences were found between the cysteamine and placebo group outcomes at both time points (p = .01, p = .02). At the end of the treatment period, MASI scores were significantly lower in the cysteamine group versus placebo (8.03 ± 5.2 vs. 12.2 ± 7.4, p = .04). IGA scores and patient viewpoints indicated significant efficacy of cysteamine cream versus placebo.

CONCLUSION

Cysteamine cream showed significant efficacy in decreasing melanin content of the lesions, as established by Dermacatch as a new measuring method.

摘要

背景

黄褐斑是一种难以治疗的色素沉着紊乱疾病。关于半胱胺治疗黄褐斑疗效的研究非常少。

目的

使用Dermacatch作为更精确的皮肤比色测量工具,确定半胱胺乳膏治疗表皮型黄褐斑患者的疗效。

方法

在一项双盲安慰剂对照研究中,参与的患者(n = 40)接受安慰剂(n = 20)或半胱胺乳膏(n = 20)治疗。在为期四个月的研究期间,每天睡前在皮损处涂抹半胱胺乳膏或安慰剂一次。通过Dermacatch和Mexameter皮肤比色法、MASI评分、研究者整体评估(IGA)以及患者问卷来确定治疗效果,所有评估均在基线、2个月和4个月检查时进行。

结果

在方案开始前,使用Dermacatch(分别为72.3±27.8和52.9±16.4)和Mexameter(分别为93.6±42.6和65.4±22.6)计算半胱胺组和安慰剂组色素沉着皮肤与正常皮肤之间的平均差异。在2个月时,半胱胺组使用Dermacatch和Mexameter测量的平均差异分别为38.1±15.3和49.9±19,安慰剂组分别为64.9±25.3和68±26.2。在4个月时,半胱胺组使用Dermacatch和Mexameter测量的平均差异分别为23.8±12.9和35.5±16.1,安慰剂组分别为50±18和51.2±16.8。在两个时间点,半胱胺组和安慰剂组的结果之间均存在统计学显著差异(p = 0.01,p = 0.02)。在治疗期结束时,半胱胺组的MASI评分显著低于安慰剂组(8.03±5.2对12.2±7.4,p = 0.04)。IGA评分和患者观点表明,与安慰剂相比,半胱胺乳膏具有显著疗效。

结论

作为一种新的测量方法,Dermacatch证实半胱胺乳膏在降低皮损黑色素含量方面具有显著疗效。

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