Safety and Effectiveness of Two High-G' Soft Tissue Fillers for Chin Augmentation: A Prospective, Randomized, Comparator-Controlled, Evaluator-Blinded Trial

两种高G值软组织填充剂用于下巴整形的安全性和有效性:一项前瞻性、随机、对照、评估者盲法试验

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Abstract

BACKGROUND: The chin is a crucial facial feature for overall attractiveness. Lower third imbalance can lead to signs of premature aging and loss of jawline contour. Effective chin augmentation with hyaluronic acid fillers has been demonstrated in the literature. Currently, however, no study has compared the safety and effectiveness of two high-G' fillers. OBJECTIVES: The objective of this study was to examine each filler's effectiveness in the correction of chin retrusion through a prospective, randomized, comparator-controlled, evaluator-blinded trial. METHODS: This study compared the safety and effectiveness of HASHA (Restylane Shaype) vs HAVLX (Juvederm Volux) for chin augmentation and correction of chin retrusion. A prospective, randomized, comparator-controlled, evaluator-blinded trial was conducted at a single research center. Forty participants aged 18 years or older with mild to severe chin retrusion were included and randomly allocated 1:1 to either HASHA (n = 20) or HAVLX (n = 20). The primary study endpoint was to examine differences in parameters associated with determining chin shape. Secondary endpoints included adverse events and patient satisfaction. RESULTS: Of the 40 participants enrolled in the trial, 37 (92.5%) were female and 3 (7.5%) were male. Although an independent-samples t-test revealed no statistically significant difference in total volumes of filler used with HAVLX (mean [standard deviation], 1.85 [0.69] mL) or HASHA (mean, 1.86 [0.89] mL, P = .953). When focused on the menton/pogonion injections, HAVLX required 15.27% more product than HASHA (mean, 1.48 mL vs 1.27 mL, P = .28). There was a statistically significant difference in efficiency score for correcting labiomental angle, with the mean efficiency score being 2.57 [1.67] for HASHA and 1.50 [1.11] for HAVLX (P = .02). CONCLUSIONS: With no statistically significant difference in overall volume utilized between HASHA and HAVLX, HASHA injections required 15.27% less volume in the menton/pogonion to achieve visual correction. Additionally, HASHA demonstrated a significantly higher efficiency score for correction of nasomental angle. Secondary endpoints were not significantly different and demonstrate that both products are safe and effective.

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