A Randomized, Investigator-Blinded, Split-Face, Controlled Trial Evaluating the Efficacy and Satisfaction of a Topical Product Containing Blueberry Extract and Pro-Xylane Combined With Micro-Focused Ultrasound for Anti-aging

一项随机、研究者盲法、半脸对照试验,评估含有蓝莓提取物和玻色因的局部用药产品联合微聚焦超声治疗衰老的疗效和满意度

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Abstract

BACKGROUND: Micro-focused ultrasound (MFUS) has been effective in treating skin aging, which manifests as skin thinning, reduced elasticity, wrinkling, etc. AIMS: This study aims to evaluate the efficacy and satisfaction of combining a product containing blueberry extract and Pro-xylane (A.G.E. cream) with MFUS in antiaging effects in the Chinese population. METHODS: In this randomized, investigator-blinded, controlled trial, patients aged 18-65 with skin roughness, sagging, laxity, or fine lines/wrinkles were enrolled. After MFUS, one side of patients' faces was randomly assigned to apply the A.G.E. cream and the other side with the standard moisturizer. Patients were followed up for 180 days. The primary endpoint was the Global Aesthetic Improvement Scale (GAIS). Secondary endpoints included percentage changes from baseline in fine lines, skin elasticity, dermal thickness, and transepidermal water loss. Patient and dermatologist satisfaction was evaluated using a questionnaire. RESULTS: A total of 50 patients were included in the study, with 49 (98%) being female. The mean ± SD age was 33.7 ± 6.4 years. For the primary endpoint, the intervention side demonstrated significant improvement in GAIS compared to the control side on Day 90 (p < 0.001). For secondary endpoints, the A.G.E. cream use after MFUS significantly improved skin elasticity at the cheeks and mouth corners on multiple follow-up days and improved fine lines at the mouth corners on Day 180. Patients and dermatologists reported higher satisfaction levels with the aesthetic outcomes of the intervention side. CONCLUSIONS: The application of the A.G.E. cream following MFUS treatment improved skin elasticity, dermal thickness, fine lines, and patient/dermatologist satisfaction. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05748470.

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