Serra Monica, Bohnert Krista, Narda Mridvika, Granger Corinne, Sadick Neil
J Drugs Dermatol. 2018 Dec 1;17(12):1310-1315.
Objective: To evaluate the safety and efficacy of ISDINCEUTICS Melaclear® serum (Barcelona, Spain) on skin brightness, skin quality, and signs of facial aging. Design: This was a single-center, observational, open label, prospective clinical study. Ten healthy females (ages 30-70) with moderate signs of facial aging and moderate photodamage (hyperpigmentation and/or sun spots) were enrolled. Treatment consisted of topical twice-daily application of Melaclear serum, morning and evening, to the face and neck for 12 weeks. Efficacy assessments were conducted at weeks 4, 8, and 12. Standardized photographs, expert investigator grading, tolerability assessments, and subjects reported outcome measures were performed at all visits. Adverse events (AEs) were monitored throughout. Visual assessments of the face and neck included grading for radiance, smoothness, pigmentation, erythema, pore size, skin clarity, skin brightness, skin tone, luminosity, skin complexion, photodamage, hyperpigmentation, wrinkle severity, pigment via the modified Melasma Area and Severity Index (MASI), and overall global aesthetic improvement (GAIS). Safety and tolerability assessments included an evaluation of face and neck for stinging/burning by the subject and dryness, scaling, edema, and erythema by the treating investigator at all study visits. Results: All enrolled subjects completed the study. At the 8 and 12-week follow up visit, there was a statistically significant improvement in the investigator GAIS (1.1 and 1.3, respectively) for the face from baseline. MASI scores were all statistically significantly reduced in the face from week 8 onward relative to baseline. In addition, all skin quality parameters assessed in the face significantly improved from baseline to week 12. Subject global aesthetic improvement scale scores (SGAIS) were also significantly improved at week twelve from baseline (1.8 change) as were skin quality assessments. The average rating for patient satisfaction was 2, or "satisfied" with the overall treatment effectiveness from week 4 onwards. For the neck none of the investigator or subject assessments improved significantly at any time point. No adverse events, tolerability events, or unexpected side effects were observed or reported for any of the subjects. Conclusion: Twice a day treatment of women with moderate facial photoaging and hyperpigmentation with Melaclear serum can significantly improve skin quality, reduce the severity and intensity of hyperpigmentation, and improve signs of photodamage within 12 weeks without any side effects. J Drugs Dermatol. 2018;17(12):1310-1315.
评估ISDINCEUTICS Melaclear®精华液（西班牙巴塞罗那）对皮肤亮度、皮肤质量和面部衰老迹象的安全性和有效性。设计：这是一项单中心、观察性、开放标签的前瞻性临床研究。招募了10名年龄在30 - 70岁之间、有中度面部衰老迹象和中度光损伤（色素沉着和/或晒斑）的健康女性。治疗方法为每天早晚两次将Melaclear精华液局部涂抹于面部和颈部，持续12周。在第4周、第8周和第12周进行疗效评估。在所有就诊时进行标准化照片拍摄、专家研究者评分、耐受性评估以及受试者报告的结局指标评估。全程监测不良事件（AE）。对面部和颈部的视觉评估包括光泽度、光滑度、色素沉着、红斑、毛孔大小、皮肤清晰度、皮肤亮度、肤色、发光度、皮肤色泽、光损伤、色素沉着、皱纹严重程度、通过改良黄褐斑面积和严重程度指数（MASI）评估的色素沉着以及整体全球美学改善（GAIS）评分。安全性和耐受性评估包括在所有研究就诊时由受试者对面部和颈部的刺痛/灼烧感进行评估，以及由治疗研究者评估干燥、脱屑、水肿和红斑情况。结果：所有入选受试者均完成了研究。在第8周和第12周的随访就诊时，面部的研究者GAIS相对于基线有统计学显著改善（分别为1.1和1.3）。从第8周起，面部的MASI评分相对于基线均有统计学显著降低。此外，从基线到第12周，面部评估的所有皮肤质量参数均有显著改善。受试者全球美学改善量表评分（SGAIS）在第12周相对于基线也有显著改善（变化1.8），皮肤质量评估也是如此。从第4周起，患者对总体治疗效果的平均满意度评分为2分，即“满意”。对于颈部，在任何时间点研究者或受试者的评估均未显著改善。未观察到或报告任何受试者出现不良事件、耐受性事件或意外副作用。结论：每天两次用Melaclear精华液治疗中度面部光老化和色素沉着的女性，可在12周内显著改善皮肤质量，降低色素沉着的严重程度和强度，并改善光损伤迹象，且无任何副作用。《药物皮肤病学杂志》。2018；17(12):1310 - 1315。
