Group of Investigative Dermatology - GRID, Dermatology Section, Department of Internal Medicine, School of Medicine, University of Antioquia, Medellín, Colombia.
J Eur Acad Dermatol Venereol. 2011 Jan;25(1):49-58. doi: 10.1111/j.1468-3083.2010.03687.x.
To date, there is no gold standard therapy for skin photoageing. In the last decade, laser technologies have offered great promise among skin-rejuvenation therapies; however, both non-ablative and ablative fractional resurfacing modalities have their own benefits and drawbacks. More recently, open-label studies and few controlled trials have suggested that photodynamic therapy may have therapeutic potential in photodamage.
To assess the efficacy of methyl aminolevulinate + red-light on facial photodamage in a double-blind split-face randomized placebo-controlled trial.
Subjects had initially two split-face treatments 2-3 weeks apart in which half of the face was treated with MAL + red-light compared with placebo + red-light. Primary outcome was the assessment of global photodamage 1 month after session 2. Secondary outcomes included the assessment of fine lines, mottled pigmentation, tactile roughness, sallowness, erythema and telangiectasia 1 month after session 2, according to severity scores rated as failure, improvement or success.
Based on the intention-to-treat analysis, a total of 48 patients (96 split-faces) were included. Facial global photodamage success or improvement had occurred in 94 split-faces and in no split-faces receiving placebo (RR: 0.02; 95% confidence interval, 0.0-0.14; P = 0.0000). One patient had an adverse event that led to the discontinuation of the therapy after session 1.
Methyl aminolevulinate + red-light demonstrated significantly superior efficacy in global facial photodamage compared with placebo. This therapy was also useful for all other specific secondary outcomes, except for telangiectasia. Overall, MAL + red-light sessions were well tolerated and resulted in high/total patient satisfaction in the majority of subjects (80.4%).
迄今为止，皮肤光老化尚无金标准疗法。在过去十年中，激光技术在皮肤年轻化治疗中展现出巨大的潜力；然而，非剥脱性和剥脱性的分波长激光治疗都有其各自的优点和缺点。最近，开放标签研究和少数对照试验表明，光动力疗法在光损伤方面可能具有治疗潜力。
在一项双盲、分面、随机安慰剂对照试验中评估氨甲环酸+红光对面部光损伤的疗效。
研究对象最初在 2-3 周内接受两次分面治疗，一半面部接受 MAL+红光治疗，另一半面部接受安慰剂+红光治疗。主要结局是在第二次治疗后 1 个月评估整体光损伤。次要结局包括在第二次治疗后 1 个月，根据严重程度评分（失败、改善或成功）评估细纹、斑驳色素沉着、触感粗糙、暗黄、红斑和毛细血管扩张的情况。
基于意向治疗分析，共纳入 48 例患者（96 个分面）。接受 MAL+红光治疗的 94 个分面和接受安慰剂的 0 个分面出现面部整体光损伤改善或成功（RR：0.02；95%置信区间，0.0-0.14；P = 0.0000）。1 例患者在第一次治疗后发生不良反应，导致治疗中断。
与安慰剂相比，氨甲环酸+红光在改善整体面部光损伤方面具有显著优势。这种治疗方法对其他所有特定的次要结局也有效，除了毛细血管扩张。总体而言，MAL+红光治疗耐受性良好，大多数患者（80.4%）满意度高/非常高。
