Clinical, Cosmetic and Investigational Dermatology (Jun 2022)
VYC-20L is Safe and Effective for Improving Volume and Aesthetic Appearance of the Nose in Chinese Adults
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 [email protected]: 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
