Prathyoosha S, Ananditha K, Narayana Rao T, Gopal K V T, Krishnam Raju P V
Department of Dermatology, Maharajah's Institute of Medical Sciences, Nellimarla, Vizianagaram Dt., Andhra Pradesh, India.
Indian Dermatol Online J. 2024 Aug 19;15(5):787-793. doi: 10.4103/idoj.idoj_797_23. eCollection 2024 Sep-Oct.
Despite the availability of various treatment modalities, the treatment of melasma is often incomplete, with a high recurrence rate. The present study was undertaken to assess the efficacy and safety of oral tranexamic acid (TXA), modified Kligman's formula (MKF), and a placebo cream in melasma.
Ninety cases of melasma of both sexes were enrolled, and divided into three groups of 30 patients each. The baseline severity of melasma was graded by Melasma Area Severity Index (MASI) score. Group A, B, and C patients were treated with oral TXA 250 mg twice daily, daily MKF cream at night, and daily placebo cream at night, respectively, for 12 weeks. Improvement in MASI score was calculated after 4, 8, and 12 weeks. At each visit, adverse effects, if any, were noted. Statistical analysis was done using Chi-square test.
Based on intention to treat analysis, at the end of 12 weeks, the reduction in MASI score in oral TXA, MKF, and placebo groups was 9.94(65.91%), 6.12(54.78%), and 2.07(17.22%), respectively ( = 0.00). The difference in reduction of mean MASI scores after 12 weeks between oral TXA group and MKF group was not significant ( = 0.29). The efficacy of oral TXA and MKB was significantly higher than that of the placebo group ( = 0.01 and = 0.03, respectively). Adverse effects in all groups were mild and self-limiting.
A limited sample size, non-blinded design, and absence of dermoscopic evaluation were the study limitations.
In view of its excellent safety profile, oral TXA may be considered as a better option for moderate to severe melasma.
尽管有多种治疗方式，但黄褐斑的治疗往往并不彻底，复发率很高。本研究旨在评估口服氨甲环酸（TXA）、改良的Kligman配方（MKF）和安慰剂乳膏治疗黄褐斑的疗效和安全性。
纳入90例男女黄褐斑患者，分为三组，每组30例。黄褐斑的基线严重程度通过黄褐斑面积严重程度指数（MASI）评分进行分级。A组、B组和C组患者分别接受每日两次口服250mg TXA、每晚使用MKF乳膏、每晚使用安慰剂乳膏治疗，为期12周。在4周、8周和12周后计算MASI评分的改善情况。每次就诊时，记录是否有不良反应。采用卡方检验进行统计分析。
基于意向性分析，在12周结束时，口服TXA组、MKF组和安慰剂组的MASI评分降低分别为9.94（65.91%）、6.12（54.78%）和2.07（17.22%）（P = 0.00）。口服TXA组和MKF组在12周后平均MASI评分降低的差异不显著（P = 0.29）。口服TXA和MKB的疗效显著高于安慰剂组（分别为P = 0.01和P = 0.03）。所有组的不良反应均较轻且为自限性。
样本量有限、非盲法设计以及缺乏皮肤镜评估是本研究的局限性。
鉴于其良好的安全性，口服TXA可被视为中重度黄褐斑的更好选择。
