在中国患者中，与TRI-LUMA相比，复方氟轻松、氢醌和维甲酸乳膏治疗中度至重度黄褐斑的疗效和安全性：一项随机、单中心、安慰剂对照试验
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.
作者信息
Hu Honghua, Zhou Pengfei, Yao Hongliang, Zhu Chengyao, Shen Bo, Feng Bo, Yu Xiangke, Liu Lunfei
机构信息
Department of Dermatology, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.
Department of Dermatology, Linping Hospital of Integrated Traditional Chinese and Western Medicine, Hangzhou, China.
出版信息
J Cosmet Dermatol. 2025 May;24(5):e70205. doi: 10.1111/jocd.70205.
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
用丙酮缩氟氢松、对苯二酚和维甲酸乳膏进行治疗是黄褐斑的金标准；然而，这种治疗方法在中国人群中的效果仍不明确。由于中国受试者与白种人受试者之间存在差异，因此需要对中国黄褐斑患者进行进一步的临床试验。
目的
评估丙酮缩氟氢松、对苯二酚和维甲酸乳膏对中国中重度黄褐斑患者的疗效和安全性。
方法
我们招募了53名患者，他们每天接受一次通用配方（三联组合乳膏，TCC）、品牌配方（TRI-LUMA）或安慰剂治疗，为期8周。在第4周和第8周，根据黄褐斑严重程度量表以及黄褐斑面积和严重程度指数评估疗效。此外，根据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
通用TCC组的有效率为52.2%，而TRI-LUMA组为57.1%。TCC组和TRI-LUMA组之间的不良反应发生率没有显著差异（分别为69.6%和90.5%；p>0.05）。安慰剂组的不良事件发生率为0%。
结论
在这项针对中国中重度黄褐斑患者的研究中，通用TCC与TRI-LUMA效果相当，且安全性相似。
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