Abstract
BACKGROUND: Skin aging is a common aesthetic concern that drives the demand for new therapeutic strategies. Lyophilized injectable recombinant humanized type III collagen (rhCol III) is an emerging biomaterial with promising regenerative potential; however, clinical data on its efficacy is limited. This study aimed to evaluate the safety and effectiveness of rhCol III in improving the signs of skin aging. METHODS: A total of 55 participants were enrolled in the study. Those in the treatment group received "water-light" intradermal injections of the study product alongside their routine skincare regimen. The control group continued with the routine skincare regimen alone. Clinical efficacy was assessed after treatment using VISIA imaging, evaluations by professional dermatologists, and self-assessments by the participants. RESULTS: Of the 52 participants who completed the follow-up (39 in the treatment group, 13 in the control group), scores on the Global Aesthetic Improvement Scale (GAIS) improved significantly in the treatment group at day 90 ± 7 (from 3.17 ± 0.39 to 2.97 ± 0.58), with no notable change in the control group. CMH chi-square analysis revealed a significant difference in response rates (71.8%; 95% CI: 54.2%-89.4%). VISIA analysis showed significant improvements in spots, wrinkles, texture, and porphyrins (corrected p < 0.00625). Generalized estimating equation (GEE) modeling supported a time-dependent cumulative effect. The treatment was well tolerated, with stable visual analogue scale (VAS) scores and no serious adverse events. CONCLUSION: This preliminary study indicates that lyophilized rhCol III can significantly improve the appearance of the skin and is safe to use.