Clinical Study on the Improvement of Nasolabial Folds and Facial Lifting by an Ampoule Containing β-Sitosterol Complex

This study aimed to evaluate the clinical efficacy of an ampoule formulated with a lipid-based delivery system containing 0.5% β-sitosterol complex for improving nasolabial folds and facial lifting. Twenty-two female participants, aged 20 to 60 years, applied the test product twice daily for a period of two weeks. Quantitative analysis of the depth and volume of nasolabial folds was performed using a 3D skin analyzer (Antera 3D CS). Safety was evaluated through visual assessment by dermatologists. After two weeks of consistent use, the depth of nasolabial folds significantly decreased by 18.52% compared to the baseline (<i>p</i><0.001). Furthermore, the volume of the nasolabial area showed a substantial improvement of 38.43%, suggesting a significant facial lifting effect (<i>p</i><0.001). All participants reported positive subjective satisfaction across all evaluation categories. No adverse skin reactions were observed during the study period, confirming the product’s safety. The observed short-term efficacy is likely attributable to the lipid-based delivery system, which employs lecithin and lamellar-forming emulsifiers to create a stratum corneum-mimetic environment. This structural similarity is proposed to facilitate the penetration of active compounds, enabling rapid barrier restoration and wrinkle improvement even at low concentrations. This study provides a clinical basis for the development of high-efficiency functional cosmetics utilizing lipid-based stabilization technology. However, as this study was conducted without a control group, the results should be interpreted as exploratory, and future studies incorporating control groups and extended application periods are warranted to further elucidate the independent contribution of β-Sitosterol.