Yazdanparast Taraneh, Ayatollahi Azin, Samadi Aniseh, Sabzvari Araz, Kafi Hamidreza, Firooz Alireza
Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran.
Medical Department, Orchid Pharmed Company, Tehran, Iran.
J Cosmet Dermatol. 2025 Apr;24(4):e70117. doi: 10.1111/jocd.70117.
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.
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.
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.
This new HA-based formulation is a safe and efficient treatment option to restore the vitality and turgidity of the skin.
ClinicalTrials.gov identifier: IRCT20150101020514N17 with ethics code IR.TUMS.TIPS.REC.1401.083.
基于透明质酸（HA）的配方在治疗包括皮肤老化在内的多种皮肤缺陷方面可能具有显著疗效。本研究的目的是评估一种高分子量和低分子量HA混合复合物注射用于皮肤年轻化的临床安全性和有效性。
在这项单臂前后临床研究中，招募了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的治疗，每次通过在五个生物美学点进行皮内注射2毫升稳定的高分子量和低分子量HA，间隔4周。疗效评估指标包括生物物理和超声参数以及全球美学改善量表（GAIS）评分。还报告了疼痛评估、安全性概况和受试者满意度。
两次随访均显示皮肤紧致度有显著改善。第一次随访时经表皮水分流失（TEWL）和真皮生态密度显著改善。第二次随访时真皮厚度有统计学意义的增加。GAIS评分中位数表明平均改善51%-75%。第一次和第二次随访的总体满意度中位数分别为7分和6分。未观察到重要的副作用。疼痛视觉模拟量表（VAS）平均评分为2分（满分10分）。
这种新的基于HA的配方是恢复皮肤活力和紧致度的安全有效治疗选择。
ClinicalTrials.gov标识符：IRCT20150101020514N17，伦理代码为IR.TUMS.TIPS.REC.1401.083。
