Gupta Pawan, Poojary Shital, Dubey Lily
Department of Dermatology, K. J. Somaiya Medical College and Hospital, Mumbai, India.
Department of Pharmacology, Bundelkhand Medical College, Sagar, Madhya Pradesh, India.
J Cutan Aesthet Surg. 2022 Apr-Jun;15(2):135-141. doi: 10.4103/JCAS.JCAS_1_21.
Melasma is an acquired chronic disorder of hyperpigmentation. Tranexamic acid (TXA) has been shown to be effective in reducing the severity of melasma.
The aim of this study is to compare the efficacy of intralesional TXA with topical Kligman's regimen in the treatment of facial melasma and to assess their safety profile.
A double arm open-labeled randomized controlled trial was conducted at a tertiary care center in western India.
Sixty-eight cases of facial melasma of either sex and age ≥ 18 years were randomized into two groups. Group A received intradermal injections of TXA 4 mg/mL, whereas group B received topical Kligman's therapy. Patients were evaluated at baseline, 4th, 8th, and 12th week semi-objectively using modified melasma area severity index (mMASI) score, physician's global assessment scale, and patient's global assessment scale.
Data were analyzed using SPSS v16 software. Mann-Whitney -test, Friedman's analysis of variance test, and Pearson's χ test were used. -value less than 0.05 was considered as statistically significant.
Fifty-nine patients completed the study. The decrease in mean mMASI score was statistically significant at 4th, 8th, and 12th week for both groups. On intergroup comparison, a statistically significant difference was observed between both the groups at 12th week ( < 0.01), with group B showing better response to therapy but no difference at baseline and at 4th and 8th week. Group A showed no significant side effects, whereas group B showed erythema, burning, and hypopigmentation in nine, six, and three patients, respectively.
Kligman's regimen remains the gold standard for melasma but with multiple serious adverse effects. Intralesional TXA is a safe and promising modality in the treatment of melasma. It can be used in non-responding cases and in those who develop side effects of Kligman's regimen.
黄褐斑是一种后天性色素沉着慢性疾病。已证明氨甲环酸（TXA）在减轻黄褐斑严重程度方面有效。
本研究旨在比较皮损内注射TXA与外用Kligman疗法治疗面部黄褐斑的疗效，并评估其安全性。
在印度西部的一家三级医疗中心进行了一项双臂开放标签随机对照试验。
68例年龄≥18岁的面部黄褐斑患者（男女不限）被随机分为两组。A组接受皮内注射4mg/mL的TXA，而B组接受外用Kligman疗法。在基线、第4周、第8周和第12周时，使用改良黄褐斑面积严重程度指数（mMASI）评分、医生整体评估量表和患者整体评估量表对患者进行半客观评估。
使用SPSS v16软件进行数据分析。采用Mann-Whitney检验、Friedman方差分析检验和Pearson χ检验。P值小于0.05被认为具有统计学意义。
59例患者完成了研究。两组在第4周、第8周和第12周时平均mMASI评分的降低均具有统计学意义。组间比较显示，两组在第12周时有统计学显著差异（P<0.01），B组对治疗的反应更好，但在基线以及第4周和第8周时无差异。A组未显示出明显副作用，而B组分别有9例、6例和3例患者出现红斑、烧灼感和色素减退。
Kligman疗法仍是黄褐斑治疗的金标准，但存在多种严重不良反应。皮损内注射TXA是一种安全且有前景的黄褐斑治疗方法。它可用于无反应的病例以及出现Kligman疗法副作用的患者。
