PMID- 33347003 OWN - NLM STAT- MEDLINE DCOM- 20210416 LR - 20230814 IS - 1524-4725 (Electronic) IS - 1076-0512 (Print) IS - 1076-0512 (Linking) VI - 47 IP - 1 DP - 2021 Jan 1 TI - Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L. PG - 80-85 LID - 10.1097/DSS.0000000000002795 [doi] AB - BACKGROUND: VYC-20L is a hyaluronic acid soft tissue filler with lidocaine designed to restore facial volume. OBJECTIVE: Evaluate the safety and effectiveness of VYC-20L in patients with chin retrusion. MATERIALS AND METHODS: Adults with chin retrusion were randomized (3:1) to receive VYC-20L in the chin at study onset (treatment group) or 6 months later (control group). The primary effectiveness end point was >/=1-point improvement on the Allergan Chin Retrusion Scale (ACRS) from baseline at Month 6. Safety assessments included injection site responses (ISRs) and adverse events (AEs). RESULTS: VYC-20L was administered to 192 participants (treatment group, n = 144; control group, n = 48). At Month 6, significantly more participants had an ACRS response in the treatment versus control group (56.3% vs 27.5%; p = .0019). Effectiveness was also demonstrated by the proportion of participants with improved/much improved Global Aesthetic Improvement Scale scores and responses on the FACE-Q Satisfaction with Chin questionnaire and FACE-Q Psychological Wellbeing module. Treatment benefit remained evident at Month 12. Most common ISRs were tenderness (81.1%) and firmness (75.1%). One participant (0.5%) discontinued the study due to 2 treatment-related serious AEs of facial cellulitis and injection site inflammation, both resolved without sequelae. CONCLUSION: VYC-20L significantly improved an ACRS response and was generally safe and well tolerated. CI - Copyright (c) 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc. FAU - Beer, Kenneth AU - Beer K AD - Beer Dermatology, West Palm Beach, Florida. FAU - Kaufman-Janette, Joely AU - Kaufman-Janette J AD - Skin Associates of South Florida, Coral Gables, Florida. FAU - Bank, David AU - Bank D AD - The Center for Dermatology, Cosmetic & Laser Surgery, Mount Kisco, New York. FAU - Biesman, Brian AU - Biesman B AD - Private Practice, Nashville, Tennessee. FAU - Dayan, Steven AU - Dayan S AD - DeNova Research, Chicago, Illinois. FAU - Kim, William AU - Kim W AD - Allergan plc, Irvine, California. FAU - Chawla, Smita AU - Chawla S AD - Allergan plc, Irvine, California. FAU - Schumacher, Andrew AU - Schumacher A AD - Allergan plc, Irvine, California. LA - eng SI - ClinicalTrials.gov/NCT02833077 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't 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 (Gels) RN - 9004-61-9 (Hyaluronic Acid) SB - IM CIN - Dermatol Surg. 2021 Feb 1;47(2):260. PMID: 33165080 MH - Adult MH - Aged MH - Aged, 80 and over MH - Cellulitis/chemically induced MH - *Chin MH - *Cosmetic Techniques MH - Dermal Fillers/*administration & dosage/adverse effects MH - Esthetics MH - Female MH - Gels MH - Humans MH - Hyaluronic Acid/*administration & dosage/adverse effects MH - Injection Site Reaction MH - Male MH - Middle Aged MH - United States PMC - PMC7752233 COIS- This study was sponsored by Allergan plc, Dublin, Ireland. Medical writing assistance was provided to the authors by W. Kim of Allergan plc, Irvine, CA. All authors met the ICMJE authorship criteria. Neither honoraria nor any other form of compensation was provided for authorship. K. Beer, J. Kaufman-Janette, D. Bank, and S. Dayan have received funding as an investigator, consultant, and trainer for Allergan. B. Biesman has received consulting fees and research funding from Allergan. W. Kim, S. Chawla, and A. Schumacher are employees of Allergan plc and may own stock in the company. EDAT- 2020/12/22 06:00 MHDA- 2021/04/17 06:00 PMCR- 2020/12/21 CRDT- 2020/12/21 14:40 PHST- 2020/12/21 14:40 [entrez] PHST- 2020/12/22 06:00 [pubmed] PHST- 2021/04/17 06:00 [medline] PHST- 2020/12/21 00:00 [pmc-release] AID - 00042728-202101000-00023 [pii] AID - ds-00017-2020 [pii] AID - 10.1097/DSS.0000000000002795 [doi] PST - ppublish SO - Dermatol Surg. 2021 Jan 1;47(1):80-85. doi: 10.1097/DSS.0000000000002795.