BACKGROUND:VYC-25L, a hyaluronic acid soft-tissue filler with lidocaine, is designed to restore and create facial volume in the chin and jaw. OBJECTIVE: To evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion. METHODS:Adults with chin retrusion (145°-165° glabella-subnasale-pogonion facial angle) were randomized (3:1) to receive VYC-25L in the chin/jaw at study onset (treatment group) or 3 months later (control group). Primary effectiveness end point was mean change in facial angle from baseline at Month 3. Safety assessments included injection site responses (ISRs), recorded in a subject diary, and adverse events (AEs). RESULTS:VYC-25L was administered to 119 subjects (treatment group: n = 90; control group: n = 29). Mean change in facial angle from baseline at Month 3 was significantly greater in the treatment versus control group (difference: 2.51°; p < .0001). Effectiveness was also demonstrated by the proportion of subjects with improved/much improved Global Aesthetic Improvement Scale scores and responses on FACE-Q Satisfaction and Psychological Well-Being Scales. Treatment benefit remained evident at Month 12. Common ISRs were firmness (95.8%), tenderness (95.8%), and swelling (91.6%). No serious treatment-related AEs were reported. CONCLUSION:VYC-25L significantly improved glabella-subnasale-pogonion facial angle and was generally safe and well tolerated.
RCT Entities:
BACKGROUND: VYC-25L, a hyaluronic acid soft-tissue filler with lidocaine, is designed to restore and create facial volume in the chin and jaw. OBJECTIVE: To evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion. METHODS: Adults with chin retrusion (145°-165° glabella-subnasale-pogonion facial angle) were randomized (3:1) to receive VYC-25L in the chin/jaw at study onset (treatment group) or 3 months later (control group). Primary effectiveness end point was mean change in facial angle from baseline at Month 3. Safety assessments included injection site responses (ISRs), recorded in a subject diary, and adverse events (AEs). RESULTS: VYC-25L was administered to 119 subjects (treatment group: n = 90; control group: n = 29). Mean change in facial angle from baseline at Month 3 was significantly greater in the treatment versus control group (difference: 2.51°; p < .0001). Effectiveness was also demonstrated by the proportion of subjects with improved/much improved Global Aesthetic Improvement Scale scores and responses on FACE-Q Satisfaction and Psychological Well-Being Scales. Treatment benefit remained evident at Month 12. Common ISRs were firmness (95.8%), tenderness (95.8%), and swelling (91.6%). No serious treatment-related AEs were reported. CONCLUSION: VYC-25L significantly improved glabella-subnasale-pogonion facial angle and was generally safe and well tolerated.
Authors: Maarten J Ottenhof; Inge J Veldhuizen; Lusanne J V Hensbergen; Louise L Blankensteijn; Wichor Bramer; Berend Vd Lei; Maarten M Hoogbergen; René R W J Hulst; Chris J Sidey-Gibbons Journal: Aesthetic Plast Surg Date: 2022-06-28 Impact factor: 2.326
Authors: María A Segurado; Fernando Urdiales-Gálvez; Paula A Benítez; Sara Carrasco; Iratxe Díaz; Nuria Escoda; Lisandro Farollch-Prats; Vitor Figueiredo; Francisco Ortíz; María Consuelo Sebastián; Luís Uva Journal: J Cosmet Dermatol Date: 2021-08-30 Impact factor: 2.189
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Authors: Raffaele Rauso; Luigi Rugge; Fabrizio Chirico; Giovanni Francesco Nicoletti; Romolo Fragola; Pierfrancesco Bove; Nicola Zerbinati; Giorgio Lo Giudice Journal: Dermatol Pract Concept Date: 2022-07-01