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含5%α - 熊果苷和2%曲酸的外用化妆品与三联复方乳膏治疗黄褐斑的疗效比较:一项半脸、评估者盲法随机对照试验

The Efficacy of Topical Cosmetic Containing Alpha-Arbutin 5% and Kojic Acid 2% Compared With Triple Combination Cream for the Treatment of Melasma: A Split-Face, Evaluator-Blinded Randomized Pilot Study.

作者信息

Tantanasrigul Pimpa, Sripha Apinya, Chongmelaxme Bunchai

机构信息

Department of Medical Services, Ministry of Public Health, Institute of Dermatology, Bangkok, Thailand.

Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand.

出版信息

J Cosmet Dermatol. 2025 Jan;24(1):e16562. doi: 10.1111/jocd.16562. Epub 2024 Nov 18.

DOI:10.1111/jocd.16562
PMID:39555866
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11740261/
Abstract

BACKGROUND

While the gold standard treatment for melasma is triple combination cream (TCC), arbutin and kojic acid demonstrate their benefits and may be used as an alternative.

AIMS

To investigate the efficacy of cream containing alpha-arbutin 5% and kojic acid 2% (AAK) compared with TCC for melasma treatment.

PATIENTS/METHODS: A split-faced, randomized study was conducted among 30 participants with melasma, and all were randomized to receive AAK or TCC on each side of their face for 12-week along with 4-week follow-up period. The melanin index (MI), modified Melasma Area Severity Index (mMASI), and physician global assessment (PGA) scores were used to measure the effectiveness of interventions. Recurrence of melasma after treatment discontinuation was evaluated by MI and mMASI. Patient satisfactions and adverse effects were also evaluated. In the analysis, the mean difference (MD) was used for MI and mMASI, while Wilcoxon signed-rank test was for the PGA scores, adverse effects, and patient satisfaction.

RESULTS

The MD of MI and mMASI scores were not different between groups (mMASI [p = 0.344] and MI [p = 0.268]). The PGA scores only showed improvement on the TCC-treated side (p = 0.032). Compared to the AKK group, the subjects with TCC showed higher severity of recurrence (MI [p = 0.004] and mMASI [p = 0.045]). No difference in patient satisfaction score between the groups, but erythema and stinging were higher in the TCC group.

CONCLUSIONS

The AAK cream appeared to be effective for melasma treatment, highlighting a lower recurrent rate and fewer adverse events than standard therapy.

TRIAL REGISTRATION

thaiclinicaltrials.org: TCTR20230124004.

摘要

背景

虽然黄褐斑的金标准治疗方法是三联组合乳膏(TCC),但熊果苷和曲酸也显示出其益处,可作为替代方法使用。

目的

研究含5%α - 熊果苷和2%曲酸的乳膏(AAK)与TCC治疗黄褐斑的疗效对比。

患者/方法:对30名黄褐斑患者进行了一项半脸随机研究,所有患者均被随机分配在其脸部两侧分别接受AAK或TCC治疗,为期12周,并进行4周的随访期。使用黑色素指数(MI)、改良黄褐斑面积严重程度指数(mMASI)和医生整体评估(PGA)评分来衡量干预措施的有效性。通过MI和mMASI评估停药后黄褐斑的复发情况。还评估了患者满意度和不良反应。在分析中,MI和mMASI使用平均差值(MD),而PGA评分、不良反应和患者满意度使用Wilcoxon符号秩检验。

结果

两组之间MI和mMASI评分的MD无差异(mMASI [p = 0.344]和MI [p = 0.268])。PGA评分仅在TCC治疗侧显示有改善(p = 0.032)。与AAK组相比,接受TCC治疗的受试者复发严重程度更高(MI [p = 0.004]和mMASI [p = 0.045])。两组患者满意度评分无差异,但TCC组的红斑和刺痛发生率更高。

结论

AAK乳膏似乎对黄褐斑治疗有效,与标准疗法相比,复发率更低,不良事件更少。

试验注册

thaiclinicaltrials.org:TCTR20230124004。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f077/11740261/9de8d97fcf93/JOCD-24-e16562-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f077/11740261/1744072909dc/JOCD-24-e16562-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f077/11740261/9de8d97fcf93/JOCD-24-e16562-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f077/11740261/1744072909dc/JOCD-24-e16562-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f077/11740261/9de8d97fcf93/JOCD-24-e16562-g002.jpg

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本文引用的文献

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Topical Hydroquinone for Hyperpigmentation: A Narrative Review.外用对苯二酚治疗色素沉着:一项叙述性综述。
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Topical and Systemic Therapies in Melasma: A Systematic Review.黄褐斑的局部和全身治疗:一项系统评价
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