Oral tranexamic acid with a triple combination cream versus oral tranexamic acid monotherapy in the treatment of severe melasma

口服氨甲环酸联合三联乳膏与口服氨甲环酸单药治疗重度黄褐斑的比较

Background: Melasma is an acquired pigmentation disorder with a complex multifactorial etiopathogenesis. Oral tranexamic acid (TA) is a promising drug for its treatment and may enhance outcomes when used in combination.

Objective: To provide evidence of the efficacy and safety of oral TA as a monotherapy, and in combination with a triple combination cream, for treating melasma in the Hispanic population.

Methods: Forty-four female Hispanic patients with melasma were randomly assigned to receive 325 mg of oral TA every 12 h plus f-TCC (fluocinolone-based triple combination cream) every 24 h (group A) or 325 mg of oral TA every 12 h (group B) for 8 weeks, after which both groups were crossed-over, and treated for an additional 8 weeks. Evaluations of the mMASI score, the melanin index, and the MelasQoL were made at baseline and Weeks 4, 8, 12, and 16.

Results: There was a 50.04% and 65.45% improvement in mMASI at Weeks 4 and 8, respectively, in group A, compared to baseline, while for Week 16, an improvement of 76.85% was achieved in group B compared to baseline. Highest scores were consistent with the use of the combined treatment modality in both groups, and were evidenced by the values of the melanin index obtained. There was no significant difference in MelasQoL scores between the 2 groups. No serious side effects were observed.

Conclusion: The combination of oral TA and f-TCC is more effective than oral TA alone in the treatment of severe melasma in Hispanic patients.

背景：黄褐斑是一种获得性色素沉着障碍，病因复杂且涉及多种因素。口服氨甲环酸（TA）是治疗该病的一种有前景的药物，联合使用时可能提高疗效。

目的：为口服TA单药治疗及联合三联组合霜治疗西班牙裔人群黄褐斑的有效性和安全性提供证据。

方法：44例西班牙裔女性黄褐斑患者被随机分配接受每12小时口服TA 325 mg联合每24小时使用f-TCC（以氟轻松为基础的三联乳膏）（A组）或每12小时口服TA 325 mg（B组），治疗8周，之后两组交叉，再治疗8周。在基线和第4、8、12和16周进行mMASI评分、黑素指数和MelasQoL评估。

结果：与基线相比，A组在第4周和第8周的mMASI分别改善50.04%和65.45%，而B组在第16周较基线改善76.85%。最高评分与两组中联合治疗模式的使用相一致，并通过所获得的黑素指数值得到证实。两组之间MelasQoL评分无显著差异。未观察到严重副作用。

结论：在西班牙裔重度黄褐斑患者中，口服TA联合f-TCC比单用口服TA更有效。

Martinez-Rico JC, Chavez-Alvarez S, Herz-Ruelas ME, Sosa-Colunga SA, Ocampo-Candiani J, Suro-Santos Y, Vazquez Martinez O. Oral tranexamic acid with a triple combination cream versus oral tranexamic acid monotherapy in the treatment of severe melasma. J Cosmet Dermatol. 2022 Aug;21(8):3451-3457. 

J of Cosmetic Dermatology - 2022.pdf