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透明质酸-烟酰胺-氨甲环酸注射用水凝胶用于改善多因素面部皮肤质量及提亮深色皮肤的临床安全性和有效性

Clinical Safety and Efficacy of Hyaluronic Acid-Niacinamide-Tranexamic Acid Injectable Hydrogel for Multifactorial Facial Skin Quality Enhancement with Dark Skin Lightening.

作者信息

Hsin Sarah, Lourenço Kelly, Porcello Alexandre, Chemali Michèle, Marques Cíntia, Raffoul Wassim, Cerrano Marco, Applegate Lee Ann, Laurent Alexis E

机构信息

Development Department, LOUNA REGENERATIVE SA, CH-1207 Geneva, Switzerland.

Plastic and Aesthetic Surgery Service, Centre Médical Lausanne Ouest, CH-1008 Prilly, Switzerland.

出版信息

Gels. 2025 Jun 26;11(7):495. doi: 10.3390/gels11070495.


DOI:10.3390/gels11070495
PMID:40710660
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12294899/
Abstract

Facial aging is a complex process manifesting as skin hyperpigmentation, textural irregularities, and a diminished elasticity, hydration, and evenness of tone. The escalating demand for minimally invasive aesthetic interventions has driven the development of advanced hydrogel-based injectable formulations. This clinical study assessed the safety and efficacy of Hydragel A1, an injectable hydrogel containing hyaluronic acid (HA), niacinamide, and tranexamic acid (TXA), designed to simultaneously address multiple facets of facial skin aging. A cohort of 49 female participants underwent a series of objective and subjective assessments, including the Global Aesthetic Improvement Scale (GAIS), instrumental measurements (Antera 3D, Chromameter, Cutometer, Dermascan, Corneometer), and standardized photographic documentation at baseline (Day 0) and 14, 28, and 70 days post-treatment. The results demonstrated statistically significant improvements in skin hydration, texture, elasticity, and pigmentation following Hydragel A1 administration. Notably, no serious adverse events or significant injection site reactions were observed, confirming the favorable safety profile of the investigated device. Collectively, these findings underscore the potential of a combined HA, niacinamide, and TXA injectable formulation to provide a comprehensive approach to facial skin rejuvenation, effectively targeting multiple aging-related mechanisms.

摘要

面部衰老是一个复杂的过程,表现为皮肤色素沉着、质地不均,以及弹性、水分含量降低和肤色不均。对微创美容干预的需求不断增加,推动了先进的水凝胶基可注射制剂的发展。这项临床研究评估了Hydragel A1的安全性和有效性,Hydragel A1是一种含有透明质酸(HA)、烟酰胺和氨甲环酸(TXA)的可注射水凝胶,旨在同时解决面部皮肤衰老的多个方面。一组49名女性参与者接受了一系列客观和主观评估,包括全球美学改善量表(GAIS)、仪器测量(Antera 3D、色差仪、皮肤弹性测试仪、皮肤扫描仪、角质层水合度测定仪),以及在基线(第0天)和治疗后14、28和70天的标准化照片记录。结果表明,注射Hydragel A1后,皮肤的水分含量、质地、弹性和色素沉着有统计学上的显著改善。值得注意的是,未观察到严重不良事件或明显的注射部位反应,证实了所研究器械良好的安全性。总的来说,这些发现强调了HA、烟酰胺和TXA联合可注射制剂在提供全面面部皮肤年轻化方法、有效针对多种衰老相关机制方面的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/e467cedd0d1e/gels-11-00495-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/6c83cdaaec39/gels-11-00495-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/0c8eedc284a2/gels-11-00495-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/cbc69e5dabc3/gels-11-00495-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/65bfbf675532/gels-11-00495-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/6b1b9646f866/gels-11-00495-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/e5b38e2f7be8/gels-11-00495-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/029bb206bdb2/gels-11-00495-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/e467cedd0d1e/gels-11-00495-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/6c83cdaaec39/gels-11-00495-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/0c8eedc284a2/gels-11-00495-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/cbc69e5dabc3/gels-11-00495-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/65bfbf675532/gels-11-00495-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/6b1b9646f866/gels-11-00495-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/e5b38e2f7be8/gels-11-00495-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/029bb206bdb2/gels-11-00495-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8f6/12294899/e467cedd0d1e/gels-11-00495-g008.jpg

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本文引用的文献

[1]
In Vitro Evaluation and Clinical Effects of a Regenerative Complex with Non-Cross-Linked Hyaluronic Acid and a High-Molecular-Weight Polynucleotide for Periorbital Treatment.

Polymers (Basel). 2025-2-27

[2]
L-lysine enhances pork color through antioxidant activity and myoglobin conformational changes.

Food Res Int. 2024-12

[3]
Injectable "Skin Boosters" in Aging Skin Rejuvenation: A Current Overview.

Arch Plast Surg. 2024-11-13

[4]
Evaluation of the Biological Effect of a Nicotinamide-Containing Broad-Spectrum Sunscreen on Photodamaged Skin.

Dermatol Ther (Heidelb). 2024-12

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Clin Cosmet Investig Dermatol. 2024-9-25

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Efficacy, Safety, Satisfaction, Adherence to Treatment With Nano-Formulated Cysteamine Tranexamic Acid Cream to Treat Melasma.

J Drugs Dermatol. 2024-7-1

[7]
Dual Functionalization of Hyaluronan Dermal Fillers with Vitamin B3: Efficient Combination of Bio-Stimulation Properties with Hydrogel System Resilience Enhancement.

Gels. 2024-5-24

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J Dermatolog Treat. 2024-12

[9]
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Tissue Barriers. 2024-5-31

[10]
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Cureus. 2024-4-29

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