目的:评价含1%视黄酸的微乳制剂脱皮的临床疗效。
方法:产品开发后,将60例黄褐斑患者随机分为3组(n=20):第1组-应用常规的1%维甲酸剥离(RA1%)。第2组-在微乳液中应用1%视黄酸剥离(RA1%M)。第3组-安慰剂的应用。这些小组接受了四次剥皮治疗,在第0、15、30和45天每两周进行一次,并以0、15、30、45和60天的时间间隔进行分析。通过使用黄褐斑面积和严重程度指数(MASI)和黄褐斑生活质量(MelascoL)仪器进行评估。还在第0天和第60天评估血液生化参数。获得结果后,正常性通过Kolmogorov-Smirnov检验和之后进行评估,应用了以下测试:弗里德曼统计学(以测试治疗对MASI指数的影响);Wilcoxon,(用于对之间的比较,以测试治疗对MelasQoL指数的影响);Kruskal-Wallis,(测试组间的差异);和曼-惠特尼,(治疗之间的比较)。采用的显著性水平为5%(α=0.05)。
结果:三组的MASI指数显着降低,表明所有治疗对减少黄褐斑的作用(p<0.001)。当与在常规媒介物(26%)和安慰剂(12%)中使用1%视黄酸的常规剥离相比时,使用在微乳液中递送的视黄酸剥离(62%)观察到污渍的显著减少。三组的MelasiQoL指数(各方面的总和)也有显著降低,表明所有治疗的效果,包括安慰剂,黄褐斑患者的整体生活质量。然而,RA1%M的治疗促进了对个体生活质量的最大影响。按百分比计算,RA1%M在MelasQoL指数中提供了30%的平均下降,而传统治疗的13%和安慰剂的4%。当在第0天和第60天比较血液生化参数时,结果没有显著变化。
结论:用RA1%M进行化学剥离治疗黄褐斑有效,并且被证明优于在常规载体中使用视黄酸进行的剥离,减少污渍,提高患者的生活质量。
OBJECTIVE: To evaluate the clinical efficacy of
peeling with a microemulsion formulation containing 1% retinoic acid.
METHODS: After development of the product, 60 patients with melasma were randomly divided into three groups (n = 20): Group 1-application of conventional 1% retinoic acid
peeling (RA 1%). Group 2-application of 1% retinoic acid
peeling in microemulsion (RA 1%M). Group 3-Application of placebo. The groups were submitted to four
peeling sessions, fortnightly on Days 0, 15, 30, and 45, and analyzed at the time intervals of 0, 15, 30, 45, and 60 days. Evaluation was made by using the Melasma Area and Severity Index (MASI) and Melasma Quality of Life (MelasquoL) instrument. Hemato-biochemical parameters were also evaluated at Days 0 and 60. After obtaining the results, normality was evaluated by means of the Kolmogorov-Smirnov test and afterwards, the following tests were applied: Friedman statistical (to test the effect of the treatments on the MASI index); Wilcoxon, (for comparison between pairs to test the effect of treatments on the MelasQoL index); Kruskal-Wallis, (to test the differences between the groups); and Mann-Whitney, (comparisons between treatments). The level of significance adopted was 5% (α = 0.05).
RESULTS: The three groups presented a significant reduction in the MASI index, indicating the effect of all the treatments on reducing the melasma (p < 0.001). A significant reduction in the stains was observed with the use of retinoic acid
peeling delivered in microemulsion (62%) when compared with the conventional peeling with 1% retinoic acid in a conventional vehicle (26%) and the placebo (12%). There was also a significant reduction in the MelasQoL index (sum of all the aspects) in the three groups, indicating the effect of all the treatments, including the placebo, on the overall quality of life of those with melasma. However, RA 1%M the treatment that promoted the greatest effect on the quality of life of individuals. In percentage terms, the RA 1%M provided a mean reduction of 30% in the MelasQoL index, against 13% of the conventional treatment and only 4% of the placebo. When the hemato-biochemical parameters were compared on Days 0 and 60, there were no significant changes in the results.
CONCLUSIONS: The chemical peeling performed with RA 1%M was effective for the treatment of melasma, and was shown to be superior to the peeling performed with retinoic acid in a conventional vehicle, in reducing the stains and improving the quality of life of patients.