Efficacy and Safety of Topical Famotidine Combined With Thulium 1927 nm Fractional Laser in the Treatment of Melasma: A Split-Face Randomized, Single-Blind, Vehicle-Controlled Clinical Trial With Long-Term Follow-Up

IF 3.7 4区医学 Q1 DERMATOLOGY

Dermatologic Therapy Pub Date : 2025-07-04 DOI:10.1155/dth/9979632

Shujuan He, Dan Ye, Simeng Qiao, Luyue Zhang, Xi Zhao, Yuxin Zhang, Jing Liu, Weihui Zeng, Zhao Wang

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Abstract

Background: Melasma is a common hyperpigmentation skin disorder with a high recurrence rate. Mast cell activation plays a role in its pathogenesis, with melanocyte activation via histamine receptor 2 (H2R) considered a potential mechanism. This study aims to evaluate the efficacy of topical famotidine combined with 1927 nm thulium fractional laser in treating melasma and reducing recurrence.

Methods: The study was designed as a split-face, randomized-controlled, single-blind trial. Participants underwent four full-face 1927 nm fractional laser treatments at 4-week intervals and applied 2% famotidine solution on a randomly assigned side and control solution on the opposite side of the face twice daily for 16 weeks. Skin assessments including VISIA imaging, modified melasma area severity index (mMASI) score, and DermaLab skin color detection were conducted by blinded dermatologists at Weeks 0, 4, 8, 12, and 16. Self-assessment scores and the melasma quality of life (MELASQoL) index were collected at baseline and Week 16. Long-term follow-up was performed at Week 64. All side effects were recorded. Statistical analyses included paired t-tests, repeated measures ANOVA, and Wilcoxon and Friedman tests.

Results: A total of 16 patients were enrolled in the study. At Week 16, the famotidine-treated side showed significant reductions in mMASI (p = 0.019, = 0.598) and melanin index (MI) (p = 0.006, = 0.672), with a slight improvement in erythema index (EI). ∆MI was significantly lower on the famotidine-treated side than the control (p = 0.012, Cohen’s d = 0.710). Both MELASQoL scores and patient self-assessments improved, with no obvious adverse effects observed. Long-term evaluation at Week 64 revealed sustained improvement in mMASI on the famotidine-treated side compared to the control side (p = 0.029, Cohen’s d = 0.686).

Conclusions: This study provides clinical evidence supporting H2R blockade as a potential melasma treatment. Famotidine may enhance laser efficacy and modulate histamine-mediated melanogenesis, offering long-term benefits in reducing recurrence.

Trial Registration: ClinicalTrials.gov identifier: NCT06313307

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法莫替丁局部联合铥1927纳米激光治疗黄褐斑的疗效和安全性：一项长期随访的裂面随机、单盲、载药对照临床试验

背景：黄褐斑是一种常见的色素沉着性皮肤病，复发率高。肥大细胞激活在其发病机制中起作用，黑素细胞通过组胺受体2 （H2R）激活被认为是一种潜在的机制。本研究旨在评价法莫替丁局部联合1927 nm铥分数激光治疗黄褐斑及减少复发的疗效。方法：本研究采用裂面、随机对照、单盲试验。参与者每隔4周接受4次全面部1927 nm分步激光治疗，并在随机指定的一侧使用2%法莫替丁溶液，在另一侧使用对照溶液，每天两次，持续16周。皮肤评估包括VISIA成像、改良黄褐斑区域严重指数（mMASI）评分和DermaLab肤色检测，由盲法皮肤科医生在第0、4、8、12和16周进行。在基线和第16周收集自评评分和黄褐斑生活质量（MELASQoL）指数。第64周进行长期随访。记录了所有的副作用。统计分析包括配对t检验、重复测量方差分析、Wilcoxon和Friedman检验。结果：共有16例患者入组。在第16周，法莫替丁治疗侧的mMASI （p = 0.019, = 0.598）和黑色素指数（MI）（p = 0.006, = 0.672）显著降低，红斑指数（EI）略有改善。法莫替定组的∆MI显著低于对照组（p = 0.012, Cohen’s d = 0.710）。MELASQoL评分和患者自我评估均有改善，未观察到明显的不良反应。第64周的长期评估显示，与对照组相比，法莫替丁治疗组的mMASI持续改善（p = 0.029, Cohen’s d = 0.686）。结论：本研究为支持H2R阻断作为一种潜在的黄褐斑治疗提供了临床证据。法莫替丁可以提高激光疗效，调节组胺介导的黑色素形成，提供减少复发的长期益处。试验注册：ClinicalTrials.gov标识符：NCT06313307

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来源期刊

Dermatologic Therapy 医学-皮肤病学

CiteScore

7.00

自引率

8.30%

发文量

711

审稿时长

3 months

期刊介绍： Dermatologic Therapy has been created to fill an important void in the dermatologic literature: the lack of a readily available source of up-to-date information on the treatment of specific cutaneous diseases and the practical application of specific treatment modalities. Each issue of the journal consists of a series of scholarly review articles written by leaders in dermatology in which they describe, in very specific terms, how they treat particular cutaneous diseases and how they use specific therapeutic agents. The information contained in each issue is so practical and detailed that the reader should be able to directly apply various treatment approaches to daily clinical situations. Because of the specific and practical nature of this publication, Dermatologic Therapy not only serves as a readily available resource for the day-to-day treatment of patients, but also as an evolving therapeutic textbook for the treatment of dermatologic diseases.