Aghdam Saba Baybordi, Mohammad Arash Pour, Hosseini-Baharanchi Fatemeh Sadat, Atefi Najmolsadat, Roohaninasab Masoumeh, Kahjoogh Hossein Ahmadi, Yazdanian Nafise, Goodarzi Azadeh
Department of Dermatology, Rasool Akram Medical Complex Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.
School of medicine, Iran University of Medical Sciences, Tehran, Iran.
J Cosmet Dermatol. 2024 Nov;23(11):3585-3597. doi: 10.1111/jocd.16464. Epub 2024 Jul 17.
The challenging management of melasma highlights the inadequacies of conventional therapies and their high risk of recurrence. Integrating microneedling for device-assisted drug delivery with tranexamic acid (TA), recognized for its melanin synthesis inhibition, presents a novel approach that warrants further investigation to fully assess its potential in enhancing melasma treatment efficacy.
Fifty moderate to severe melasma patients participated in this randomized outcome-assessor-blinded controlled trial. Patients were randomly allocated into two main groups. Group A received a modified Kligman formula on one hemi-face on alternate nights for 2 months (A1) and three sessions of microneedling with 10% topical TA on the other hemi-face at 1-month intervals (A2). Group B used the same modified Kligman formula on both sides of the face, with one side additionally receiving three sessions of microneedling with 4% TA (B1) and the opposite side with 10% TA (B2). Primary outcomes were % Modified Melasma Area and Severity Index (mMASI) and % visual analogue scale (VAS) change during 6 month follow-up. Adverse events including post-inflammatory hyperpigmentation (PIH) and treatment tolerability were recorded.
Compared to baseline, the mean mMASI reduction immediately after the final session was higher in A1, B1, and B2 (56.84%, 50.88%, and 55.87%, respectively) than in A2, which saw only a 13.16% reduction. Efficacy notably declined after the cessation of treatment across all groups. While the efficacy within groups A1, B1, and B2 was comparable, microneedling with 4% or 10% TA combined with the topical modified Kligman formula proved more potent in patients at a lower risk of PIH. Overall, 22% of patients reported PIH, particularly in the A2 group (28% of hemi-faces), with its occurrence significantly associated with treatment during warmer seasons and in darker skin phototypes. Other adverse events were not observed in any patient. Patient satisfaction was highest in groups B1 and B2, where approximately 72% reported 'excellent' satisfaction. The lowest durability rate (16%) was observed in group A2, while the highest (72%) was seen in group B2, comparable with groups A1 and B1. Treatment tolerability was reported 100% in all groups.
It was found that the modified Kligman formula outperformed microneedling-TA alone. However, with optimal patient selection, particularly targeting those at lower risk for PIH with lighter skin phototypes and scheduling treatments during less-sunny seasons, combining microneedling with 4% or 10% TA and the modified Kligman formula significantly enhanced efficacy and satisfaction rates compared to conventional topical treatment.
黄褐斑具有挑战性的治疗凸显了传统疗法的不足及其高复发风险。将微针用于辅助药物递送并结合氨甲环酸（TA），TA因其抑制黑色素合成而闻名，这提出了一种新方法，值得进一步研究以全面评估其在提高黄褐斑治疗效果方面的潜力。
五十名中度至重度黄褐斑患者参与了这项随机、评估者盲法的对照试验。患者被随机分为两个主要组。A组在一侧半脸每隔一晚使用改良的Kligman配方，持续2个月（A1），在另一侧半脸每隔1个月进行三次微针治疗并使用10%的外用TA（A2）。B组在脸的两侧使用相同的改良Kligman配方，一侧额外接受三次使用4%TA的微针治疗（B1），另一侧使用10%TA（B2）。主要结局是6个月随访期间改良黄褐斑面积和严重程度指数（mMASI）的变化百分比以及视觉模拟量表（VAS）的变化百分比。记录包括炎症后色素沉着（PIH）和治疗耐受性在内的不良事件。
与基线相比，最后一次治疗后立即观察到，A1、B1和B2组的平均mMASI降低幅度更高（分别为56.84%、50.88%和55.87%），而A2组仅降低了13.16%。所有组在治疗停止后疗效均显著下降。虽然A1、B1和B2组内的疗效相当，但对于PIH风险较低的患者，使用4%或10%TA联合外用改良Kligman配方的微针治疗效果更佳。总体而言，22%的患者报告有PIH，尤其是A2组（半脸的28%），其发生与温暖季节和较深肤色的光型患者接受治疗显著相关。未在任何患者中观察到其他不良事件。B1和B2组患者满意度最高，约72%的患者报告“非常满意”。A2组的持久率最低（16%），而B2组最高（72%），与A1和B1组相当。所有组的治疗耐受性报告均为100%。
发现改良的Kligman配方比单独的微针 - TA治疗效果更好。然而，通过优化患者选择，特别是针对PIH风险较低、皮肤光型较浅的患者，并在阳光较少的季节安排治疗，与传统局部治疗相比，将微针与4%或10%TA以及改良的Kligman配方相结合可显著提高疗效和满意度。
