A型肉毒毒素治疗黄褐斑的疗效：一项半脸随机对照研究。

Efficacy of Botulinum Toxin A for the Management of Melasma: A Split-Face, Randomized Control Study.

作者信息

Chaijaras Sasipim, Boonpethkaew Suphagan, Chirasuthat Sonphet, Sakpuwadol Nawara, Yongpisarn Tanat, Anansiripun Pimsiri, Vachiramon Vasanop

机构信息

Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Division of Dermatology, School of Medicine, Walailak University, Nakhon Si Thammarat, Thailand.

出版信息

J Cosmet Dermatol. 2025 Aug;24(8):e70376. doi: 10.1111/jocd.70376.

DOI:10.1111/jocd.70376

PMID:40747795

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12315078/

Abstract

BACKGROUND

Melasma management remains challenging due to its multifactorial nature pathogenesis and recurrent nature. Previous studies showed positive effects of botulinum toxin A (BoNT-A) for treating and preventing ultraviolet-induced hyperpigmentation.

OBJECTIVE

To evaluate the effectiveness of adjunctive incoBoNT-A injection combined with triple combination cream (TCC, 4% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide) for treating and preventing melasma recurrence compared to topical therapy alone.

METHODS

A split-face study was conducted in 30 female patients with melasma. One side of the face was randomly applied TCC to the melasma-affected areas for 12 weeks (monotherapy), while the contralateral side received TCC and intradermal incoBoNT-A at baseline and week 12 (combination therapy side). Evaluations were performed at baseline and 2, 4, 8, 12, 16, 20, and 24 weeks. Clinical improvement and melanin index were assessed using the MASI score on the malar area (MASI), and Colorimeter respectively. Patient satisfaction was also evaluated.

RESULTS

Twenty-eight subjects completed the study. The combination therapy side showed significant MASI decrease at week 2 (p = 0.0032), while the monotherapy side showed no significant change. At 4 weeks, a greater reduction of MASI was observed in the combination therapy side (MASI 14.5 and 11.54, 20.41% reduction) when compared to the monotherapy side (MASI 11.68 and 11.79, 0.93% worsening). At week 12, worsening of melasma was observed on both sides during the summer period. At week 24 (3 months after discontinuing TCC), MASI was 14.79 on the monotherapy side (worsen 21.03% from baseline) and 9.14 on the combined technique (36.97% improvement, p = 0.0003). Patients' satisfaction was higher for the combination therapy when compared to the monotherapy at the end of the study (8.92 vs. 7.04, p < 0.0001). No serious adverse events occurred.

CONCLUSION

Intradermal incoBoNT-A injection combined with TCC demonstrated superior efficacy in melasma treatment and recurrence prevention compared to TCC monotherapy.

摘要

背景

黄褐斑的治疗颇具挑战性，因其发病机制具有多因素性且易复发。既往研究表明，肉毒杆菌毒素A（BoNT-A）对治疗和预防紫外线诱发的色素沉着有积极作用。

目的

评估与单纯局部治疗相比，辅助性皮内注射incoBoNT-A联合三联组合乳膏（TCC，4%氢醌、0.05%维甲酸和0.01%醋酸氟轻松）治疗和预防黄褐斑复发的有效性。

方法

对30例黄褐斑女性患者进行了一项半脸研究。面部一侧的黄褐斑受累区域随机涂抹TCC，持续12周（单一疗法），而另一侧在基线和第12周接受TCC和皮内注射incoBoNT-A（联合疗法组）。在基线以及第2、4、8、12、16、20和24周进行评估。分别使用面颊部黄褐斑面积和严重程度指数（MASI）评分以及色度仪评估临床改善情况和黑色素指数。还评估了患者满意度。

结果

28名受试者完成了研究。联合疗法组在第2周时MASI显著降低（p = 0.0032），而单一疗法组无显著变化。在第4周时，与单一疗法组（MASI分别为11.68和11.79，恶化0.93%）相比，联合疗法组的MASI降低幅度更大（MASI分别为14.5和11.54，降低20.41%）。在第12周时，夏季期间两侧黄褐斑均出现加重。在第24周（停用TCC 3个月后），单一疗法组的MASI为14.79（较基线恶化21.03%），联合疗法组为9.14（改善36.97%，p = 0.0003）。在研究结束时，联合疗法组患者的满意度高于单一疗法组（8.92对7.04，p < 0.0001）。未发生严重不良事件。