背景:黄褐斑的治疗具有挑战性,突出了常规疗法的不足之处和高复发风险。整合微针用于与氨甲环酸(TA)的装置辅助药物递送,因其黑色素合成抑制而被认可,提出了一种新颖的方法,值得进一步研究,以充分评估其在增强黄褐斑治疗功效方面的潜力。
方法:50名中度至重度黄褐斑患者参加了这项随机结局评估盲法对照试验。患者被随机分为两个主要组。A组在交替的夜晚在一个半面接受改良的Kligman配方,持续2个月(A1),并在另一个半面以1个月的间隔(A2)接受3次微针治疗,其中10%的局部TA。B组在面部两侧使用相同的改良Kligman配方,一侧额外接受三个阶段的4%TA(B1)和10%TA(B2)的另一侧。主要结果为6个月随访期间改良黄褐斑面积和严重程度指数(mMASI)和视觉模拟评分(VAS)变化百分比。记录不良事件,包括炎症后色素沉着过度(PIH)和治疗耐受性。
结果:与基线相比,A1、B1和B2在最后一次会议后立即降低的平均mMASI更高(56.84%,50.88%,55.87%,分别)比A2下降了13.16%。在所有组停止治疗后,功效显著下降。A1、B1和B2组的疗效相当,4%或10%TA的微针结合局部改良的Kligman配方被证明对PIH风险较低的患者更有效。总的来说,22%的患者报告PIH,特别是在A2组(28%的半面),其发生与在温暖的季节和较深的皮肤光型中的治疗显着相关。在任何患者中均未观察到其他不良事件。B1组和B2组患者满意度最高,其中约72%报告“优秀”满意度。在A2组中观察到最低的耐久性率(16%),而在B2组中观察到最高的耐久性率(72%),与A1和B1组相当。所有组的治疗耐受性报告为100%。
结论:发现改良的Kligman配方优于单独的微针疗法-TA。然而,通过最佳的患者选择,特别是针对那些在低风险的PIH与较轻的皮肤照型和安排治疗在阳光较少的季节,与常规局部治疗相比,将微针与4%或10%TA和改良的Kligman配方相结合,显着提高了疗效和满意度。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.