Safety and Efficacy of a “High and Low Molecular Weight Hyaluronic Acid Hybrid Complex” Injection for Face Rejuvenation

IF 2.3 4区 医学 Q2 DERMATOLOGY
Taraneh Yazdanparast, Azin Ayatollahi, Aniseh Samadi, Araz Sabzvari, Hamidreza Kafi, Alireza Firooz
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Abstract

Introduction

Hyaluronic acid (HA)-based formulations could have remarkable efficacy in treating a wide range of skin defects, including skin aging. The purpose of the study was the evaluation of the clinical safety and efficacy of a high and low molecular weight HA hybrid complex injection for skin rejuvenation.

Method

In this single-arm, before-and-after clinical study, 20 subjects with wrinkled, dry, or rough skin were enrolled. They received two treatment sessions, each of 2 mL of stabilized high- and low-molecular-weight HA through intradermal injections in five bioaesthetic points with an interval of 4 weeks. Efficacy assessment measures included biophysical and sonographic parameters and the Global Aesthetic Improvement Scale (GAIS) score. Pain assessment, safety profile, and subject satisfaction were also reported.

Results

A significant improvement in skin firmness was demonstrated in both follow-up visits. The Transepidermal water loss (TEWL) and the dermis ecodensity improved significantly in the first follow-up visit. A statistically significant increase in the dermis thickness was seen in the second follow-up visit. The median GAIS score indicated an average improvement of 51%–75%. The median overall satisfaction score was 7 and 6 in the first and second follow-up visits. No important side effects were observed. The average pain VAS score was 2 out of 10.

Conclusion

This new HA-based formulation is a safe and efficient treatment option to restore the vitality and turgidity of the skin.

Trial Registration

ClinicalTrials.gov identifier: IRCT20150101020514N17 with ethics code IR.TUMS.TIPS.REC.1401.083

Abstract Image

注射 "高低分子量透明质酸混合复合物 "用于面部年轻化的安全性和有效性
透明质酸(HA)为基础的配方可能有显著的疗效,治疗广泛的皮肤缺陷,包括皮肤老化。该研究的目的是评估高分子量和低分子量透明质酸混合复合物注射用于皮肤年轻化的临床安全性和有效性。方法在这项单臂、前后对照的临床研究中,纳入20名皮肤有皱纹、干燥或粗糙的受试者。他们接受了两个疗程,每个疗程2毫升稳定的高分子量和低分子量透明质酸,通过皮内注射5个生物美容点,间隔4周。疗效评价指标包括生物物理指标、超声指标和GAIS评分。疼痛评估、安全性和受试者满意度也被报道。结果两组患者的皮肤紧致度均有明显改善。经皮失水(TEWL)和真皮生态密度在第一次随访中显著改善。在第二次随访中,真皮厚度有统计学意义的显著增加。GAIS评分中位数显示平均改善51%-75%。第一次和第二次随访的满意度中位数分别为7分和6分。没有观察到重要的副作用。平均疼痛VAS评分为2分(满分10分)。结论该新配方是一种安全有效的恢复皮肤活力和浮肿的治疗选择。临床试验注册:ClinicalTrials.gov标识符:IRCT20150101020514N17,伦理代码为IR.TUMS.TIPS.REC.1401.083
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来源期刊
CiteScore
4.30
自引率
13.00%
发文量
818
审稿时长
>12 weeks
期刊介绍: The Journal of Cosmetic Dermatology publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques. The scope of coverage includes, but will not be limited to: healthy skin; skin maintenance; ageing skin; photodamage and photoprotection; rejuvenation; biochemistry, endocrinology and neuroimmunology of healthy skin; imaging; skin measurement; quality of life; skin types; sensitive skin; rosacea and acne; sebum; sweat; fat; phlebology; hair conservation, restoration and removal; nails and nail surgery; pigment; psychological and medicolegal issues; retinoids; cosmetic chemistry; dermopharmacy; cosmeceuticals; toiletries; striae; cellulite; cosmetic dermatological surgery; blepharoplasty; liposuction; surgical complications; botulinum; fillers, peels and dermabrasion; local and tumescent anaesthesia; electrosurgery; lasers, including laser physics, laser research and safety, vascular lasers, pigment lasers, hair removal lasers, tattoo removal lasers, resurfacing lasers, dermal remodelling lasers and laser complications.
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