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

Abstract

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