Safety and Efficacy of Low-Temperature Gel of Recombinant Humanized Type III Collagen in the Treatment of Midface Volume Deficit.

IF 3 2区医学 Q1 SURGERY

Aesthetic Surgery Journal Pub Date : 2025-09-16 DOI:10.1093/asj/sjaf168

Yue Zhang, Baolin Zhang, Lixia Qiu, Peng Zhao, Xin Yan, Yao Jia

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引用次数: 0

Abstract

Background: Midface volume loss contributes significantly to facial contour changes. Congenital traits, genetic predisposition, and environmental factors can reduce collagen fiber quantity and quality, leading to decreased skin firmness, wrinkles, and midface depression. Type III collagen, abundant in the human body, has low immunogenicity, good tissue compatibility, and promising biomedical applications. However, employing animal-derived collagen, typically in liquid form, is limited by potential adverse reactions and disease transmission.

Objectives: To assess the safety and efficacy of localized injections of low-temperature gel recombinant humanized Type III collagen (rhCol III) in treating midface volume deficit.

Methods: In vivo animal experiments and retrospective clinical data analysis were conducted.

Results: Low-temperature gel rhCol III significantly improved facial volume and midfacial contour with a favorable safety profile in subchronic systemic toxicity tests in Sprague-Dawley rats, skin degradation studies in New Zealand white rabbits, and human clinical trials. In humans, the treatment group showed significant improvement in Merz Aesthetic Scale, Global Aesthetic Improvement Scale, and satisfaction scores vs controls at 1 month (P < .0001), with effects lasting at least 6 months.

Conclusions: Low-temperature gel rhCol III offers a safe, effective, and durable option for correcting midface volume deficit, with minimal risk of complications. These results suggest potential value in enhancing clinical strategies for facial volume restoration.

Level of evidence: 3 (therapeutic):

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重组人源型胶原低温凝胶治疗中脸体积缺损的安全性和有效性。

背景：中脸体积损失对面部轮廓变化有重要影响。先天特征、遗传易感性和环境因素会降低胶原纤维的数量和质量，导致皮肤紧致度下降、皱纹和中脸凹陷。III型胶原蛋白在人体中含量丰富，免疫原性低，组织相容性好，具有良好的生物医学应用前景。然而，由于潜在的不良反应和疾病传播，使用动物源性胶原蛋白（通常为液体形式）受到限制。目的：评价低温凝胶重组人源ⅲ型胶原蛋白（rhCol III）局部注射治疗中脸体积缺损的安全性和有效性。方法：进行动物体内实验和回顾性临床资料分析。结果：在Sprague-Dawley大鼠的亚慢性全身毒性试验、新西兰大白兔的皮肤降解研究和人体临床试验中，低温凝胶rhCol III显著改善了面部体积和面部中部轮廓，具有良好的安全性。在人类中，治疗组在1个月时在Merz美学量表、全球美学改善量表和满意度评分上与对照组相比有显著改善（P < 0.0001），效果持续至少6个月。结论：低温凝胶rhCol III提供了一种安全、有效、持久的选择，用于纠正中脸容积不足，并发症风险最小。这些结果提示了加强面部体积修复的临床策略的潜在价值。证据等级：3（治疗性）：

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来源期刊

Aesthetic Surgery Journal SURGERY-

CiteScore

6.20

自引率

20.70%

发文量

309

审稿时长

6-12 weeks

期刊介绍： Aesthetic Surgery Journal is a peer-reviewed international journal focusing on scientific developments and clinical techniques in aesthetic surgery. The official publication of The Aesthetic Society, ASJ is also the official English-language journal of many major international societies of plastic, aesthetic and reconstructive surgery representing South America, Central America, Europe, Asia, and the Middle East. It is also the official journal of the British Association of Aesthetic Plastic Surgeons, the Canadian Society for Aesthetic Plastic Surgery and The Rhinoplasty Society.