PMID- 31135570 OWN - NLM STAT- MEDLINE DCOM- 20200113 LR - 20200113 IS - 1524-4725 (Electronic) IS - 1076-0512 (Linking) VI - 45 IP - 10 DP - 2019 Oct TI - Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel. PG - 1294-1303 LID - 10.1097/DSS.0000000000001960 [doi] AB - 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 degrees -165 degrees 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 degrees ; 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. FAU - Ogilvie, Patricia AU - Ogilvie P AD - SkinConcept, Munich, Germany. FAU - Sattler, Gerhard AU - Sattler G AD - Rosenpark Klinik, Darmstadt, Germany. FAU - Gaymans, Frodo AU - Gaymans F AD - Private Practice, Amsterdam, the Netherlands. FAU - Belhaouari, Lakhdar AU - Belhaouari L AD - Centre de Chirurgie Esthetique, Toulouse, France. FAU - Weichman, Barry M AU - Weichman BM AD - BMW Associates, Monroe Township, New Jersey. FAU - Snow, Sean AU - Snow S AD - Allergan plc, Irvine, California. FAU - Chawla, Smita AU - Chawla S AD - Allergan plc, Irvine, California. FAU - Abrams, Steve AU - Abrams S AD - Allergan plc, Irvine, California. FAU - Schumacher, Andrew AU - Schumacher A AD - Allergan plc, Irvine, California. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Dermatol Surg JT - Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] JID - 9504371 RN - 0 (Dermal Fillers) RN - 0 (Drug Combinations) RN - 9004-61-9 (Hyaluronic Acid) RN - 98PI200987 (Lidocaine) SB - IM MH - Adult MH - Aged MH - Chin MH - Cosmetic Techniques/*adverse effects MH - Dermal Fillers/*administration & dosage/adverse effects MH - Drug Combinations MH - Esthetics MH - Female MH - Humans MH - Hyaluronic Acid/*administration & dosage/adverse effects MH - Injection Site Reaction/epidemiology MH - Jaw MH - Lidocaine/*administration & dosage/adverse effects MH - Male MH - Middle Aged MH - Patient Satisfaction MH - Skin Aging/*drug effects MH - Treatment Outcome MH - Young Adult EDAT- 2019/05/29 06:00 MHDA- 2020/01/14 06:00 CRDT- 2019/05/29 06:00 PHST- 2019/05/29 06:00 [pubmed] PHST- 2020/01/14 06:00 [medline] PHST- 2019/05/29 06:00 [entrez] AID - 10.1097/DSS.0000000000001960 [doi] PST - ppublish SO - Dermatol Surg. 2019 Oct;45(10):1294-1303. doi: 10.1097/DSS.0000000000001960.