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在有面部色素沉着的有色人种受试者中,将诊室化学换肤与外用综合色素沉着控制产品联合使用。

Combination of In-Office Chemical Peels With a Topical Comprehensive Pigmentation Control Product in Skin of Color Subjects With Facial Hyperpigmentation.

作者信息

Downie Jeanine, Schneider Katie, Goberdhan Lisa, Makino Elizabeth T, Mehta Rahul C

出版信息

J Drugs Dermatol. 2017 Apr 1;16(4):301-306.

Abstract

Dyschromia is one of the primary complaints for patients with skin of color. Treatments need to achieve a balance between tolerability and efficacy to address existing hyperpigmentation without causing additional damage that could trigger post-inflammatory hyperpigmentation (PIH). An open-label, single-center study was conducted to assess the efficacy of a novel comprehensive pigmentation control serum (LYT2) combined with a series of three very superficial chemical peels (VP) in skin of color subjects. Seventeen female and male subjects aged 36 to 69 years with Fitzpatrick Skin Types III-VI and moderate to severe facial hyperpigmentation were enrolled in the 12-week clinical study. Subjects identified as Asian, Hispanic, African American, or Caucasian ethnicities. Subjects received a series of 3 VP treatments every 4 weeks. LYT2 was applied twice-daily in between VP treatments. Investigator assessments for overall hyperpigmentation, overall photodamage, and skin tone unevenness, as well as standardized digital photography and subject self-assessment questionnaires were conducted at all visits (baseline and weeks 4, 8, and 12). In vivo reflectance confocal microscopy (RCM) of a target lesion was conducted (in a subset of subjects) at baseline and week 12. Fourteen subjects completed the study. The treatment regimen provided statistically significant improvements in all efficacy parameters at weeks 8 and 12 (all P less than equal to 0.03, student's t-test). Standardized digital photography and RCM images support the improvements in overall hyperpigmentation observed by the investigator. At the end of treatment, the regimen was highly rated by subjects with 100% of subjects (strongly agree/agree) that the combination "decreased the appearance of uneven skin tone and discolorations" and "reduced the appearance of sun damage." In addition to this clinical study, independent case studies with this combination treatment regimen at a separate study site were also conducted with results that corroborate the formal clinical study findings. The comprehensive results from these studies suggest that the combination of a comprehensive pigmentation control serum with a series of 3 very superficial chemical peels may provide an effective treatment approach for hyperpigmentation in skin of color patients.

J Drugs Dermatol. 2017;16(4):301-306.

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摘要

色素沉着异常是有色人种皮肤患者的主要诉求之一。治疗需要在耐受性和疗效之间取得平衡,以解决现有的色素沉着问题,同时避免造成可能引发炎症后色素沉着(PIH)的额外损伤。开展了一项开放标签、单中心研究,以评估一种新型综合色素沉着控制血清(LYT2)联合一系列三次极浅化学剥脱术(VP)对有色人种皮肤受试者的疗效。17名年龄在36至69岁之间、Fitzpatrick皮肤类型为III - VI型且面部有中度至重度色素沉着的男性和女性受试者参加了这项为期12周的临床研究。受试者包括亚洲人、西班牙裔、非裔美国人或白种人。受试者每4周接受一系列3次VP治疗。在VP治疗期间,LYT2每天涂抹两次。在所有访视(基线以及第4、8和12周)时进行研究者对整体色素沉着、整体光损伤和肤色不均的评估,以及标准化数码摄影和受试者自我评估问卷。在基线和第12周(部分受试者)对目标病变进行体内反射式共聚焦显微镜(RCM)检查。14名受试者完成了研究。该治疗方案在第8周和第12周时在所有疗效参数上均有统计学显著改善(所有P≤0.03,学生t检验)。标准化数码摄影和RCM图像支持了研究者观察到的整体色素沉着改善情况。在治疗结束时,该方案得到受试者的高度评价,100%的受试者(强烈同意/同意)认为该联合治疗“减少了肤色不均和色素沉着的外观”以及“减少了阳光损伤的外观”。除了这项临床研究外,在另一个研究地点也进行了该联合治疗方案的独立病例研究,结果证实了正式临床研究的发现。这些研究的综合结果表明,一种综合色素沉着控制血清联合一系列3次极浅化学剥脱术可能为有色人种皮肤患者的色素沉着提供一种有效的治疗方法。

《皮肤药物学杂志》2017年;16(4):301 - 306。

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