Shihab Nahla, Prihartono Joedo, Tovar-Garza Andrea, Agustin Triana, Legiawati Lili, Pandya Amit G
Department of Dermatology and Venereology, Universitas Indonesia, Jakarta, Indonesia.
Department of Community Medicine, Universitas Indonesia, Jakarta, Indonesia.
Australas J Dermatol. 2020 Aug;61(3):237-242. doi: 10.1111/ajd.13267. Epub 2020 Feb 28.
BACKGROUND/OBJECTIVES: Melasma is a common pigmentary disorder for which oral tranexamic acid has shown some efficacy in previous studies. The aim of this study was to assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.
Subjects with moderate-to-severe melasma were enrolled. Group A received hydroquinone 4% cream, sunscreen and oral tranexamic acid, while Group B received hydroquinone 4% cream, sunscreen and placebo capsules for 3 months. All subjects had an additional 3-month follow-up visit on sunscreen alone. The primary outcome measure was change in modified Melasma Area and Severity Index (mMASI) score. In addition, the melanin index was measured using a mexameter.
Fifty subjects were enrolled, and all completed the study. There was a 55% reduction in mMASI after 3 months from mean 8.96 (SD 2.45) to 4.0 (SD 1.6) in Group A compared to 10.9% from mean 8.53 (SD 2.04) to 7.6 (SD 2.0) in Group B. Three months after oral and topical therapy was discontinued, there was a 42% decrease in mMASI compared to baseline in Group A (mean 5.1 SD 1.7) vs. 4.7% in Group B (mean 8.1 SD 2.0). No serious adverse events were observed.
A combination of oral tranexamic acid and topical hydroquinone is more effective than hydroquinone alone in the treatment of melasma.
背景/目的：黄褐斑是一种常见的色素沉着紊乱疾病，此前的研究表明口服氨甲环酸有一定疗效。本研究旨在评估口服氨甲环酸联合氢醌乳膏治疗黄褐斑的有效性。
招募中重度黄褐斑患者。A组接受4%氢醌乳膏、防晒霜和口服氨甲环酸治疗，而B组接受4%氢醌乳膏、防晒霜和安慰剂胶囊治疗，为期3个月。所有受试者在仅使用防晒霜的情况下进行了额外3个月的随访。主要观察指标是改良黄褐斑面积和严重程度指数（mMASI）评分的变化。此外，使用皮肤黑色素仪测量黑色素指数。
共招募了50名受试者，所有受试者均完成了研究。A组在3个月后mMASI从平均8.96（标准差2.45）降至4.0（标准差1.6），降低了55%，而B组从平均8.53（标准差2.04）降至7.6（标准差2.0），降低了10.9%。在停止口服和外用治疗3个月后，A组的mMASI较基线下降了42%（平均5.1，标准差1.7），而B组下降了4.7%（平均8.1，标准差2.0）。未观察到严重不良事件。
口服氨甲环酸和外用氢醌联合治疗黄褐斑比单独使用氢醌更有效。
