Efficacy and Safety of Generic Fluocinolone Acetonide, Hydroquinone, and Tretinoin Cream Compared With TRI-LUMA for the Treatment of Moderate-To-Severe Melasma in Chinese Patients: A Randomized, Single-Center, Placebo-Controlled Trial

仿制氟轻松氢醌维A酸乳膏与TRI-LUMA治疗中国中重度黄褐斑患者的有效性和安全性比较：一项随机、单中心、安慰剂对照试验

Background: Treatment with fluocinolone acetonide, hydroquinone, and tretinoin cream is the gold standard for melasma; however, the effects of this treatment in the Chinese population remain unclear. Due to the differences between Chinese and Caucasian subjects, further clinical trials in Chinese patients with melasma are needed.

Aim: To evaluate the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin creams in Chinese patients with moderate-to-severe melasma.

Methods: We recruited 53 patients who received a generic formulation (triple combination cream, TCC), brand formulation (TRI-LUMA), or placebo once daily for 8 weeks. In weeks 4 and 8, efficacy was evaluated based on the Melasma Severity Scale and Melasma Area and Severity Index. In addition, safety was assessed based on the incidence and severity of treatment-emergent adverse events.

Results: The generic TCC group achieved 52.2% efficacy compared to 57.1% in the TRI-LUMA group. There was no significant difference in the incidence of adverse effects between the TCC and TRI-LUMA groups (69.6% and 90.5%, respectively; p > 0.05). The incidence of adverse events in the placebo group was 0%.

Conclusion: Generic TCC was as effective as TRI-LUMA and had a similar safety profile in this study of Chinese subjects with moderate-to-severe melasma.

背景：氟轻松氢醌维A酸乳膏治疗是黄褐斑的金标准；然而，该治疗在中国人群中的效果仍不明确。由于中国受试者与白人受试者之间存在差异，需要在中国黄褐斑患者中开展进一步的临床试验。

目的：评估氟轻松氢醌维A酸乳膏治疗中国中重度黄褐斑患者的有效性和安全性。

方法：我们招募了53例患者，分别接受仿制剂（三联乳膏，TCC）、原研药（TRI-LUMA）或安慰剂，每日一次，共8周。在第4周和第8周，基于黄褐斑严重程度量表和黃褐斑面积和严重程度指数评估有效性。此外，基于治疗中出现的不良事件的发生率和严重程度评估安全性。

结果：TCC组有效率为52.2%，TRI-LUMA组为57.1%。TCC组与TRI-LUMA组不良事件发生率无显著差异（分别为69.6%和90.5%；p > 0.05）。安慰剂组不良事件发生率为0%。

结论：在中国中重度黄褐斑受试者的本研究中，仿制TCC与TRI-LUMA同样有效，且安全性特征相似。

Hu H, Zhou P, Yao H, Zhu C, Shen B, Feng B, Yu X, Liu L. Efficacy and Safety of Generic Fluocinolone Acetonide, Hydroquinone, and Tretinoin Cream Compared With TRI-LUMA for the Treatment of Moderate-To-Severe Melasma in Chinese Patients: A Randomized, Single-Center, Placebo-Controlled Trial. J Cosmet Dermatol. 2025 May;24(5):e70205.

202505- 治疗中重度黄褐斑疗效安全随机单中心安慰剂对照-.pdf