Beer Dermatology, West Palm Beach, Florida.
Skin Associates of South Florida, Coral Gables, Florida.
Dermatol Surg. 2021 Jan 1;47(1):80-85. doi: 10.1097/DSS.0000000000002795.
VYC-20L is a hyaluronic acid soft tissue filler with lidocaine designed to restore facial volume.
Evaluate the safety and effectiveness of VYC-20L in patients with chin retrusion.
Adults with chin retrusion were randomized (3:1) to receive VYC-20L in the chin at study onset (treatment group) or 6 months later (control group). The primary effectiveness end point was ≥1-point improvement on the Allergan Chin Retrusion Scale (ACRS) from baseline at Month 6. Safety assessments included injection site responses (ISRs) and adverse events (AEs).
VYC-20L was administered to 192 participants (treatment group, n = 144; control group, n = 48). At Month 6, significantly more participants had an ACRS response in the treatment versus control group (56.3% vs 27.5%; p = .0019). Effectiveness was also demonstrated by the proportion of participants with improved/much improved Global Aesthetic Improvement Scale scores and responses on the FACE-Q Satisfaction with Chin questionnaire and FACE-Q Psychological Wellbeing module. Treatment benefit remained evident at Month 12. Most common ISRs were tenderness (81.1%) and firmness (75.1%). One participant (0.5%) discontinued the study due to 2 treatment-related serious AEs of facial cellulitis and injection site inflammation, both resolved without sequelae.
VYC-20L significantly improved an ACRS response and was generally safe and well tolerated.
VYC-20L 是一种含有利多卡因的透明质酸软组织填充剂,旨在恢复面部体积。
评估 VYC-20L 在颏后缩患者中的安全性和有效性。
颏后缩的成年人在研究开始时(治疗组)或 6 个月后(对照组)随机(3:1)接受 VYC-20L 颏部注射。主要有效性终点是在第 6 个月时颏部后退量表(ACRS)从基线至少改善 1 分。安全性评估包括注射部位反应(ISR)和不良事件(AE)。
VYC-20L 共治疗了 192 名参与者(治疗组 144 名,对照组 48 名)。在第 6 个月时,治疗组的 ACRS 应答者比例明显高于对照组(56.3% vs 27.5%;p =.0019)。通过改善/明显改善的全球美学改善量表评分比例以及对 FACE-Q 颏部满意度问卷和 FACE-Q 心理幸福感模块的应答,也证明了疗效。治疗益处在第 12 个月仍然明显。最常见的 ISR 是压痛(81.1%)和硬结(75.1%)。1 名患者(0.5%)因 2 例与治疗相关的严重不良事件(面部蜂窝织炎和注射部位炎症)而退出研究,均无后遗症。
VYC-20L 显著改善了 ACRS 应答,且通常安全且耐受良好。