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烟酰胺联合5兆赫超声的局部制剂改善皮肤老化:一项双盲、随机、安慰剂对照的临床研究。

Topical Formulation with Niacinamide Combined with 5 MHz Ultrasound for Improving Skin Ageing: A Double-blind, Randomised, Placebo-controlled Clinical Study.

作者信息

Vergilio Mariane Massufero, Leonardi Gislaine Ricci

机构信息

Pós-graduação em Clínica Médica, Faculdade de Ciências Médicas - Universidade Estadual de Campinas (UNICAMP), SP, Brasil.

Faculdade de Ciências Farmacêuticas - Universidade Estadual de Campinas (UNICAMP), SP, Brasil.

出版信息

Curr Med Chem. 2024 Aug 21. doi: 10.2174/0109298673325125240813075250.

DOI:10.2174/0109298673325125240813075250
PMID:39171587
Abstract

INTRODUCTION

Skin ageing is a complex process influenced by various factors. Personal care products claim to address ageing signs, yet clinical efficacy tests lack standardised regulations. Niacinamide (NIA) is known for skin benefits, including managing hyperpigmentation and enhancing the barrier function. The 5 MHz unfocused ultrasound (5-US) is a technological intervention for cutaneous ageing, lacking sufficient literature. This study aimed to clinically assess a topical formulation with NIA, combined with facial application of unfocused 5-US.

METHODS

Sixty-seven female subjects (30-60 years) with signs of aged skin participated in the study. They were enrolled and randomised into four groups: (A) placebo formulation, (B) cosmetic formulation, (C) placebo formulation plus 5-US, and (D) cosmetic formulation plus 5-US. Groups C and D performed the aesthetic procedure of 5-US on the entire face, in a total time of 20 minutes per session, once per week (eight total sessions). Clinical, instrumental, and subjective assessments were performed before (T0) and during the eighth week (T8) of the study.

RESULTS

The formulation with NIA improved stratum corneum aqueous content and reduced transepidermal water loss. Sebum reduction was observed in groups utilising the formulation. Consumer evaluations indicated improvements in appearance, firmness, elasticity, and reduced wrinkles, notably in Groups C and D. Sensory analysis indicated overall product acceptability.

CONCLUSION

The formulation with NIA improved skin hydration and reduced sebum content in mature skin, while subjective evaluations indicated qualitative improvements in skin appearance. Although 5-US alone did not show instrumental improvements, protocol adjustments and longer study periods may yield better results. The comprehensive approach provides an innovative perspective into potential synergies, suggesting future directions for anti-ageing interventions in skin care.

摘要

引言

皮肤老化是一个受多种因素影响的复杂过程。个人护理产品宣称可解决老化迹象,但临床疗效测试缺乏标准化规范。烟酰胺(NIA)因其对皮肤的益处而闻名,包括改善色素沉着和增强屏障功能。5兆赫非聚焦超声(5-US)是一种针对皮肤老化的技术干预手段,相关文献不足。本研究旨在对含烟酰胺的局部配方进行临床评估,并结合面部非聚焦5-US应用。

方法

67名有皮肤老化迹象的30至60岁女性参与了该研究。她们被招募并随机分为四组:(A)安慰剂配方组,(B)化妆品配方组,(C)安慰剂配方加5-US组,以及(D)化妆品配方加5-US组。C组和D组在整个面部进行5-US美容程序,每次疗程共20分钟,每周一次(共八次疗程)。在研究开始前(T0)和第八周(T8)进行临床、仪器和主观评估。

结果

含烟酰胺的配方改善了角质层含水量,减少了经表皮水分流失。使用该配方的组观察到皮脂减少。消费者评价表明外观、紧致度、弹性有所改善,皱纹减少,特别是在C组和D组。感官分析表明产品总体可接受。

结论

含烟酰胺的配方改善了成熟皮肤的水合作用并减少了皮脂含量,而主观评价表明皮肤外观有定性改善。虽然单独的5-US未显示出仪器测量方面的改善,但方案调整和更长的研究期可能会产生更好的结果。这种综合方法为潜在协同作用提供了创新视角,为皮肤护理抗老化干预指明了未来方向。

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