1. VYC-20L is Safe and Effective for Improving Volume and Aesthetic Appearance of the Nose in Chinese Adults
- Author
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Li D, Sun J, Zhang Y, Wang X, Yang S, Harvey C, and Zhang L
- Subjects
dermal fillers ,hyaluronic acid ,injections ,nose ,rhinoplasty ,Dermatology ,RL1-803 - Abstract
Dong Li,1 Jiaming Sun,2 Yuguang Zhang,3 Xiaojun Wang,4 Songlin Yang,5 Candice Harvey,6 Lijuan Zhang7 1Department of Plastic Surgery, Peking University Third Hospital, Beijing, People’s Republic of China; 2Depatment of Plastic Surgery, Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People’s Republic of China; 3Department of Plastic Surgery, Shanghai 9th People’s Hospital, Shanghai, People’s Republic of China; 4Department of Plastic Surgery, Peking Union Medical College Hospital, Beijing, People’s Republic of China; 5Department of Plastic Surgery Shanghai 6th People’s Hospital, Shanghai, People’s Republic of China; 6Clinical Development, Allergan Aesthetics, an AbbVie Company, Marlow, UK; 7Clinical Development, Allergan Aesthetics, an AbbVie Company, Beijing, People’s Republic of ChinaCorrespondence: Dong Li, Peking University Third Hospital, No. 49 North Garden Road, Haidian District, Beijing, 100191, People’s Republic of China, Tel +86 10 8226 6699, Fax +86 10 8226 6116, Email lidong9@sina.comPurpose: Soft tissue filler injection is less invasive than surgical approaches for facial aesthetic improvement. This study evaluated the safety and effectiveness of the soft tissue filler VYC-20L (Juvéderm Voluma® XC) for improvement of volume and aesthetic appearance of the nose in Chinese subjects.Patients and Methods: In a prospective, multicenter, no-treatment–controlled study in China, adult subjects were randomized 3:1 to receive VYC-20L (treatment group) or have optional treatment delayed by 24 weeks (control group). The treatment group received VYC-20L on day 1 plus optional touch-up at week 8 for suboptimal improvement. The primary effectiveness measure was mean change in nose area volume from baseline to week 24 by digital analysis of three-dimensional (3D) images. Multiple secondary effectiveness and safety measures were assessed.Results: Of 164 subjects randomized, 162 were treated, and 157 comprised the modified intent-to-treat population (mean age, 31 years; 94% female). In the treatment group, mean VYC-20L volume injected was 1.18 mL (initial treatment) and 0.67 mL (touch-up; n = 46 [38.3%]). VYC-20L achieved significantly larger changes in nose area volume than control at week 24 (2.032 vs ‒0.005 cm3, respectively; p < 0.0001) and greater improvements on the Global Aesthetic Improvement Scale (investigator and subject), Nose Satisfaction Scale, and other 3D measures. No treatment-related adverse events occurred. Most injection site responses were mild/moderate, resolving within 14 days. Mean initial/touch-up treatment procedural pain ratings were less than 3 (0‒10 scale; higher = worse pain).Conclusion: VYC-20L is safe and effective for nose augmentation in Chinese adults.Keywords: dermal fillers, hyaluronic acid, injections, nose, rhinoplasty
- Published
- 2022