Bruce Suzanne
The Center for Skin Research, Houston, TX, USA.
J Drugs Dermatol. 2013 Mar;12(3):S27-31.
Abnormal accumulation of melanin is a common aesthetic skin concern. For years, the gold standard for the treatment of hyperpigmentary disorders has been 4% hydroquinone (HQ). Due to regulatory agencies around the world questioning the safety of HQ, there has been interest in developing new HQ-free skin brightening/lightening products. A multimodality product (skin brightening complex) addressing various pathways for melanogenesis was developed as an alternative to HQ.
The skin brightening complex was studied for efficacy and tolerability in subjects with moderate to severe facial hyperpigmentation.
Subjects were instructed to apply skin brightening complex to the entire face twice daily and to follow a standard skin care regimen (facial cleanser, moisturizer, and sunscreen) during the course of the study. The study was conducted over a 12-week period and consisted of evaluation visits at baseline and at weeks 4, 8, and 12. At each visit, subjects were evaluated by an investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs and spectrophotometric assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. To assess longer-term safety and efficacy, 10 subjects elected to continue treatment for an additional 12 weeks (24 weeks total), with evaluations at weeks 18 and 24.
Twenty-six subjects completed the 12-week study, and 8 subjects completed treatment for an additional 12 weeks (24 weeks in total). In the 12-week study, the skin brightening complex was shown to be effective and significantly improved Overall Hyperpigmentation at weeks 4, 8, and 12 compared with baseline. The skin brightening complex also significantly improved the Mottled Pigmentation Area and Severity Index ([MoPASI], a modified Melasma Area and Severity Index [MASI] scale) at weeks 8 and 12 compared with baseline. These efficacy benefits continued at 24 weeks. The product was well tolerated at all evaluation visits. Subject questionnaires showed 80% or more of the subjects reporting pigmentation improvement and satisfaction with the skin brightening complex at all evaluation visits.
This HQ-free skin brightening complex was effective and well tolerated in subjects with facial hyperpigmentation who were treated for as long as 24 weeks.
黑色素异常积聚是常见的皮肤美容问题。多年来，治疗色素沉着紊乱的金标准一直是4%的对苯二酚（HQ）。由于世界各地的监管机构对HQ的安全性提出质疑，人们开始关注开发不含HQ的新型亮肤/美白产品。一种针对黑色素生成的多种途径的多模态产品（皮肤美白复合物）被开发出来作为HQ的替代品。
研究皮肤美白复合物对中度至重度面部色素沉着患者的疗效和耐受性。
受试者被指示每天两次将皮肤美白复合物涂抹于整个面部，并在研究过程中遵循标准的皮肤护理方案（洁面乳、保湿霜和防晒霜）。该研究为期12周，包括在基线以及第4、8和12周的评估访视。每次访视时，由研究人员使用分级量表对受试者的临床疗效和耐受性进行评估。还拍摄了标准化数码照片和进行了分光光度评估。在第4、8和12周完成自我评估问卷。为评估长期安全性和疗效，10名受试者选择继续治疗额外的12周（总共24周），并在第18和24周进行评估。
26名受试者完成了12周的研究，8名受试者又完成了12周的治疗（总共24周）。在12周的研究中，与基线相比，皮肤美白复合物在第4、8和12周显示出有效，并显著改善了总体色素沉着。与基线相比，皮肤美白复合物在第8和12周还显著改善了斑点色素沉着面积和严重程度指数（[MoPASI]，一种改良的黄褐斑面积和严重程度指数[MASI]量表）。这些疗效在24周时持续存在。该产品在所有评估访视中耐受性良好。受试者问卷显示，在所有评估访视中，80%或更多的受试者报告色素沉着有改善，并对皮肤美白复合物感到满意。
这种不含HQ的皮肤美白复合物对接受长达24周治疗的面部色素沉着患者有效且耐受性良好。
