Atefi Najmolsadat, Dalvand Behzad, Ghassemi Mahammadreza, Mehran Golnaz, Heydarian Amir
Dermatology Department, Rasoul-e-Akram Hospital, Iran University of Medical Science, Tehran, Iran.
Dermatol Ther (Heidelb). 2017 Sep;7(3):417-424. doi: 10.1007/s13555-017-0195-0. Epub 2017 Jul 26.
Few studies have focused on therapeutic as well as side effects of tranexamic acid (TXA) as a topical drug compared to other topical drugs in treating melasma. The present study aimed to assess and compare the beneficial therapeutic effects and also side effects of local TXA in comparison with hydroquinone in treating women with melasma.
This randomized double-blinded clinical trial was performed on 60 women who suffered from melasma and were referred to the skin disorders clinic at the Rasoul-e-Akram hospital in Tehran in 2015. The patients were then randomly assigned via computerized randomization to two groups: group A received TXA%5 (topically twice a day for 12 weeks in the location of the melasma) and group B (received hydroquinone 2% with the same treatment order). Prior to intervention and at 12 weeks after intervention, the intensity and extension of melasma were assessed based on the Melasma Area and Severity Index (MASI) scoring method.
The mean MASI score in both treatment groups decreased considerably after completion of treatment and was not significant between the two groups. No side effects were detected in group A, but 10% of those in group B complained of drug-related side effects including erythema and skin irritation (p = 0.131). Regarding the level of patient satisfaction, the patients in group A had a significantly higher level of satisfaction level of 33.3% compared with 6.7% in group B (p = 0.015) (Fig. 9). Multivariate linear regression modeling with the presence of age, history of systemic disorder, drug history, and family history of melasma demonstrated no difference in the mean MASI between the two groups.
Topical use of TXA significantly reduced both melanin level and MASI score. Given its high efficiency and low drug side effects, this regimen results in high patient satisfaction compared with topical hydroquinone. IRCT code: IRCT2016040627220N2.
与其他用于治疗黄褐斑的局部用药相比,很少有研究关注氨甲环酸(TXA)作为局部用药的治疗效果及副作用。本研究旨在评估并比较局部应用TXA与氢醌治疗女性黄褐斑的有益治疗效果及副作用。
2015年,对60名患有黄褐斑并前往德黑兰拉苏勒-阿克拉姆医院皮肤病诊所就诊的女性进行了这项随机双盲临床试验。然后通过计算机随机化将患者随机分为两组:A组接受5%的TXA(在黄褐斑部位每天局部用药两次,持续12周),B组接受2%的氢醌(用药顺序相同)。在干预前及干预后12周,根据黄褐斑面积和严重程度指数(MASI)评分方法评估黄褐斑的强度和范围。
两个治疗组在治疗结束后平均MASI评分均显著降低,两组之间无显著差异。A组未检测到副作用,但B组有10%的患者抱怨出现与药物相关的副作用,包括红斑和皮肤刺激(p = 0.131)。关于患者满意度,A组患者的满意度水平显著高于B组,分别为33.3%和6.7%(p = 0.015)(图9)。对年龄、全身疾病史、用药史和黄褐斑家族史进行多变量线性回归建模,结果显示两组之间平均MASI无差异。
局部应用TXA可显著降低黑色素水平和MASI评分。鉴于其高效性和低药物副作用,与局部应用氢醌相比,该治疗方案可提高患者满意度。伊朗临床试验注册代码:IRCT2016040627220N2。