Novel Supplement with Phenolic Compounds for Treatment of Melasma: Double Blind Placebo Controlled Trial Safety and Efficacy Evaluation

J. Downie, N. A. Abdullah
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Abstract

Background: Melasma is a chronic skin problem that causes dark, discolored patches on the skin and therefore can have adverse effects on quality of life. Recently, a novel complex was shown to decrease melasma. Specifically, the goal of the study was to prove that the formula can reduce melasma, overall hyperpigmentation and nontransient erythema. Objectives: The primary efficacy outcome measure was a minimum of 50% improvement of the modified melasma area and severity index (mMASI) score from the baseline at the 90 day follow-up visit. Secondary outcomes were overall hyperpigmentation score collection and analyses, patient’s self-assessment regarding their non-transient erythema score when evaluated across the whole patient population at the baseline and at 90 days and the analyses of adverse events. Methods: Forty subjects with Fitzpatrick skin types III-V were enrolled in the double-blinded, randomized, placebo controlled trial: 20 were treated over 90 days with the oral supplement and 20 received a placebo over 90 days. Subjects were assessed at onset and re-assessed at 60 and 90 days by the Modified Melasma Area and Severity Index (mMASI), photographic documentation, hyperpigmentation tool, erythema index and client satisfaction. Subjects used the product or a placebo (in tablet form) orally once a day. Results: At 90 days, the modified melasma area and severity index score (mMASI) improved by more than 50% in 75% of cases (p<0.001), thus indicating treatment efficacy. There was a greater decrease in mMASI for the supplement group vs placebo (-3.28 for the active arm vs. -0.73 for the placebo arm, p<0.001). Furthermore, at the 90-day follow-up visit, the overall hyperpigmentation and non-transient erythema scores (p<0.001) improved significantly: by 55% and 38%, respectively. Results obtained from patients showed overall satisfaction with the therapy course and results. The product was well tolerated, with no reports of adverse events or side effects. Conclusion: Consistent, statistically significant reductions in melasma, as measured by mMASI scores, overall hyperpigmentation and non-transient erythema scores were achieved while meeting patient expectations at the 90 day follow-up evaluation point when compared to placebo. Results from this clinical trial suggest that this oral supplement is an effective treatment for melasma and may provide an alternative treatment for overall hyperpigmentation and non-transient erythema, while meeting expectations of patients. The product was well tolerated, with no reports of adverse events or side effects.
新型酚类化合物补充剂治疗黄褐斑:双盲安慰剂对照试验安全性和疗效评价
背景:黄褐斑是一种慢性皮肤问题,会导致皮肤上出现深色、变色的斑块,因此会对生活质量产生不利影响。最近,一种新的复合物被证明可以减少黄褐斑。具体来说,研究的目的是证明该配方可以减少黄褐斑,整体色素沉着和非短暂性红斑。目的:主要疗效指标是在90天随访时,改良黄褐斑面积和严重程度指数(mMASI)评分较基线至少改善50%。次要结果是总体色素沉着评分收集和分析,患者在基线和90天对整个患者群体的非短暂性红斑评分进行自我评估,以及不良事件分析。方法:40名患有III-V型Fitzpatrick皮肤的受试者被纳入双盲、随机、安慰剂对照试验:20名接受口服补充剂治疗90天以上,20名接受安慰剂治疗90天以上。通过改良黄褐斑面积和严重程度指数(mMASI)、摄影记录、色素沉着工具、红斑指数和客户满意度对受试者在发病时进行评估,并在60天和90天再次进行评估。受试者使用该产品或安慰剂(片剂形式),每天口服一次。结果:治疗90 d时,75%的患者改良黄褐斑面积和严重程度指数评分(mMASI)改善超过50% (p<0.001),表明治疗有效。与安慰剂组相比,补充组的mMASI下降幅度更大(活动组为-3.28,安慰剂组为-0.73,p<0.001)。此外,在90天的随访中,总体色素沉着和非短暂性红斑评分(p<0.001)分别显著改善了55%和38%。患者对治疗过程及效果总体满意。该产品耐受性良好,没有不良事件或副作用的报告。结论:与安慰剂相比,在90天的随访评估点,通过mMASI评分、总体色素沉着和非短暂性红斑评分来衡量,黄褐斑的减少具有一致的统计学意义,同时满足了患者的期望。本临床试验结果表明,该口服补充剂是治疗黄褐斑的有效方法,可能为整体色素沉着和非短暂性红斑提供替代治疗,同时满足患者的期望。该产品耐受性良好,没有不良事件或副作用的报告。
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