背景:光生物调节(PBM)已被建议作为黄褐斑的替代治疗方法。体外研究表明,琥珀色的PBM抑制酪氨酸酶,诱导自噬并降低黑色素含量,但仍需要随机对照临床试验。本研究旨在评估琥珀色PBM(590nm)与脂质体氨甲环酸相比治疗黄褐斑的疗效。
方法:这项研究是一项对照研究,随机化,双盲,非自卑审判。这项研究将在两个中心进行(大学NovedeJulho设施,Vergueiro校区,和Galache牙病诊所,南圣卡塔诺,都在圣保罗州,巴西)。样品(54名参与者)将以1:1的比例分为两组;一组将接受活性PBM和安慰剂化妆品,另一组将接受假PBM和脂质体氨甲环酸。出现面部黄褐斑的女性,35-50岁,皮肤光型II-IV,将有资格列入。使用口服避孕药的妇女,宫内节育器,激素替代或光敏药物,患有自身免疫性疾病的患者和在过去3个月内接受过面部治疗的患者将被排除在研究之外.参与者将每周接受12周的PBM,在此期间每天在家使用两次化妆品。黄褐斑的严重程度将通过黄褐斑面积和严重程度指数(MASI)作为主要结果进行评估;通过角质层评估表皮的色素沉着,摄影记录,面部的全球诊断和生活质量问卷(巴西葡萄牙语版的黄褐斑生活质量问卷)将被评估为次要结局.所有评估将在开始研究之前进行(第0周),研究中期在6周和治疗完成时(第12周)。MASI也将在随访期间(第16周和第20周)进行评估。将使用广义混合模型根据意向治疗分析对数据进行分析,和α<0.05将被认为是统计学上显著的。
背景:该方案得到了NovedeJulho大学研究伦理委员会的批准(5332384)。所有参与者将填写患者知情同意书。在该试验中获得的结果将在会议上提交并提交出版。
背景:ClinicalTrials.gov注册表(NCT05326997)。
Photobiomodulation (PBM) has been suggested as an alternative treatment for melasma. In vitro studies have shown PBM with amber light inhibits the tyrosinase enzyme, induces autophagy and reduces the melanin content, but randomised controlled clinical trials are still needed. This study aims to evaluate the efficacy of amber PBM (590 nm) in the treatment of melasma compared with liposomal tranexamic acid.
This study is a controlled, randomised, double-blind, non-inferiority trial. This study will be performed in two centres (Universidade Nove de Julho Facility, Campus Vergueiro, and Galache Odontology Clinic, São Caetano do Sul, both in São Paulo State, Brazil). The sample (54 participants) will be divided into two groups in a 1:1 ratio; one group will receive active PBM and a placebo cosmetic and the other will receive sham PBM and liposomal tranexamic acid. Women presenting facial melasma, aged 35-50 years, with skin phototypes II-IV, will be eligible for inclusion. Women who use oral contraceptives, intrauterine devices, hormone replacement or photosensitive drugs, those with autoimmune disease and those who have undergone facial treatments in the last 3 months will be excluded from the study. The participants will receive PBM weekly for 12 weeks and will use the cosmetic two times per day at home during this period. The severity of melasma will be evaluated through the Melasma Area and Severity Index (MASI) as the primary outcome; pigmentation of the epidermis evaluated by corneomelametry, the photographic records, the global diagnosis of the face and the quality-of-life questionnaire (Brazilian Portuguese version of the Melasma Quality of Life Questionnaire) will assessed as secondary outcomes. All assessments will be made before starting the study (week 0), mid-study at 6 weeks and at the completion of treatment (week 12). MASI will also be evaluated during follow-up (weeks 16 and 20). The data will be analysed based on the intention-to-treat analysis using a generalised mixed model, and α <0.05 will be considered statistically significant.
The protocol was approved by the Research Ethics Committee of Universidade Nove de Julho (5 332 384). All participants will fill out the patient informed consent form. The results obtained in this trial will be presented at conferences and submitted for publication.
ClinicalTrials.gov Registry (NCT05326997).