Niforos Francois, Acquilla Raj, Ogilvie Patricia, Safa Marva, Signorini Massimo, Creutz Lela, Kerson Graeme, Silberberg Michael
*Centre Chirurgical Niforos, Lyon, France; †The Gatehouse, Cheshire, United Kingdom; ‡SkinConcept, Munich, Germany; §La Jouvence, Neuchâtel, Switzerland; ‖Private Practice, Milan, Italy; ¶Peloton Advantage, Parsippany, New Jersey; #Allergan Plc, Marlow, United Kingdom.
Dermatol Surg. 2017 Oct;43(10):1271-1280. doi: 10.1097/DSS.0000000000001127.
Infraorbital skin depressions are one of the most troublesome facial areas for aesthetically aware patients.
Evaluate effectiveness and safety of Juvéderm Volbella with Lidocaine (VYC-15L; Allergan plc, Dublin, Ireland) for correction of bilateral infraorbital depressions.
In this 12-month, prospective, uncontrolled, open-label study, subjects aged ≥18 years with infraorbital depressions rated ≥1 on the Allergan Infra-oRbital Scale (AIRS) received injections of VYC-15L with optional touch-up treatment on Day 14. The primary efficacy measure was ≥1 AIRS grade improvement from baseline at month 1.
Of 80 subjects initially treated with VYC-15L, 75 (94%) completed the study. All injections were intentionally deep, most using multiple microbolus technique. At 1 month, 99.3% of eyes achieved ≥1 AIRS grade improvement. The responder rate (subjects with ≥1 AIRS grade improvement in both eyes) was 99% at month 1, 92% at month 6, and 54% at month 12. Most injection site reactions (e.g., bruising, redness, irregularities/bumps) were mild and resolved by day 14. Late-onset mild to moderate edema was observed in 11% of eyes at month 6% and 4% of eyes at month 12.
VYC-15L is effective and safe for the treatment of infraorbital depressions, with effectiveness lasting up to 12 months.
眶下皮肤凹陷是注重美观的患者最困扰的面部区域之一。
评估含利多卡因的乔雅登Volbella（VYC - 15L；爱尔兰都柏林艾尔建公司）矫正双侧眶下凹陷的有效性和安全性。
在这项为期12个月的前瞻性、非对照、开放标签研究中，年龄≥18岁、眶下凹陷在艾尔建眶下量表（AIRS）上评分≥1分的受试者在第1天接受VYC - 15L注射，并可选择在第14天进行补打治疗。主要疗效指标是在第1个月时较基线AIRS等级改善≥1级。
最初用VYC - 15L治疗的80名受试者中，75名（94%）完成了研究。所有注射均有意打得较深，多数采用多次微推注技术。在第1个月时，99.3%的眼睛AIRS等级改善≥1级。有反应者比例（双眼AIRS等级改善≥1级的受试者）在第1个月时为99%，第6个月时为92%，第12个月时为54%。多数注射部位反应（如瘀斑、发红、不平整/肿块）较轻，在第14天消退。在第6个月时，11%的眼睛出现迟发性轻度至中度水肿，在第12个月时，4%的眼睛出现该情况。
VYC - 15L治疗眶下凹陷有效且安全，疗效可持续长达12个月。
