Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L.
Journal
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
ISSN: 1524-4725
Titre abrégé: Dermatol Surg
Pays: United States
ID NLM: 9504371
Informations de publication
Date de publication:
01 01 2021
01 01 2021
Historique:
entrez:
21
12
2020
pubmed:
22
12
2020
medline:
17
4
2021
Statut:
ppublish
Résumé
VYC-20L is a hyaluronic acid soft tissue filler with lidocaine designed to restore facial volume. Evaluate the safety and effectiveness of VYC-20L in patients with chin retrusion. 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). 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. VYC-20L significantly improved an ACRS response and was generally safe and well tolerated.
Sections du résumé
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.
Identifiants
pubmed: 33347003
doi: 10.1097/DSS.0000000000002795
pii: 00042728-202101000-00023
pmc: PMC7752233
doi:
Substances chimiques
Dermal Fillers
0
Gels
0
Hyaluronic Acid
9004-61-9
Banques de données
ClinicalTrials.gov
['NCT02833077']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
80-85Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.
Références
Jones D, Flynn TC. Hyaluronic acids: clinical applications. In: Jonas D, editor. Injectable Fillers: Principles and Practice. Oxford, United Kingdom: Blackwell Publishing Ltd.; 2010; pp. 158–74.
American Society of Plastic Surgeons. 2008 Minimally-Invasive Cosmetic Procedures. Available from: https://www.plasticsurgery.org/documents/News/Statistics/2008/plastic-surgery-statistics-full-report-2008.pdf . Accessed January 30, 2020.
American Society of Plastic Surgeons. 2018 Cosmetic Surgical Procedures. 2018. Available from: https://www.plasticsurgery.org/documents/News/Statistics/2008/plastic-surgery-statistics-full-report-2018.pdf . Accessed January 30, 2020.
Alam M, Tung R. Injection technique in neurotoxins and fillers: indications, products, and outcomes. J Am Acad Dermatol 2018;79:423–35.
Jones D, Murphy DK. Volumizing hyaluronic acid filler for midface volume deficit: 2-year results from a pivotal single-blind randomized controlled study. Dermatol Surg 2013;39:1602–12.
Lee EI. Aesthetic alteration of the chin. Semin Plast Surg 2013;27:155–60.
de Maio M, Wu WTL, Goodman GJ, Monheit G; Alliance for the Future of Aesthetics Consensus C. Facial assessment and injection guide for botulinum toxin and injectable hyaluronic acid fillers: focus on the lower face. Plast Reconstr Surg 2017;140:393e–404e.
Naini FB, Donaldson AN, McDonald F, Cobourne MT. Assessing the influence of chin prominence on perceived attractiveness in the orthognathic patient, clinician and layperson. Int J Oral Maxillofac Surg 2012;41:839–46.
Sykes JM. Rejuvenation of the aging neck. Facial Plast Surg 2001;17:99–107.
Kridel RWH, Patel S. Cheek and chin implants to enhance facelift results. Facial Plast Surg 2017;33:279–84.
Fedok FG, Mittelman H. Augmenting the prejowl: deciding between fat, fillers, and implants. Facial Plast Surg 2016;32:513–9.
Callan P, Goodman GJ, Carlisle I, Liew S, et al. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol 2013;6:81–9.
Raspaldo H. Volumizing effect of a new hyaluronic acid sub-dermal facial filler: a retrospective analysis based on 102 cases. J Cosmet Laser Ther 2008;10:134–42.
Hoffmann K; Juvederm Voluma Study Investigators G. Volumizing effects of a smooth, highly cohesive, viscous 20-mg/mL hyaluronic acid volumizing filler: prospective European study. BMC Dermatol 2009;9:9.
Carruthers J, Carruthers A, Tezel A, Kraemer J, et al. Volumizing with a 20-mg/mL smooth, highly cohesive, viscous hyaluronic acid filler and its role in facial rejuvenation therapy. Dermatol Surg 2010;36(Suppl 3):1886–92.
Fischer TC. A European evaluation of cosmetic treatment of facial volume loss with Juvederm Voluma in patients previously treated with Restylane Sub-Q. J Cosmet Dermatol 2010;9:291–6.
Hexsel D, Soirefmann M, Porto MD, Siega C, et al. Double-blind, randomized, controlled clinical trial to compare safety and efficacy of a metallic cannula with that of a standard needle for soft tissue augmentation of the nasolabial folds. Dermatol Surg 2012;38:207–14.
Sivek R, Emer J. Use of a blunt-tipped microcannula for soft tissue filler injection in the treatment of linear scleroderma (en coup de sabre). Dermatol Surg 2014;40:1439–41.
Sahan A, Karaosmanoglu N, Ozdemir Cetinkaya P. Chin augmentation with the use of cannula from a single, midline entry point: evaluation of 50 patients. J Cosmet Dermatol 2020;19:1301–6.
Sadeghpour M, Quatrano NA, Bonati LM, Arndt KA, et al. Delayed-onset nodules to differentially crosslinked hyaluronic acids: comparative incidence and risk assessment. Dermatol Surg 2019;45:1085–94.
Funt D, Pavicic T. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches. Clin Cosmet Investig Dermatol 2013;6:295–316.
Belmontesi M, Grover R, Verpaele A. Transdermal injection of Restylane SubQ for aesthetic contouring of the cheeks, chin, and mandible. Aesthet Surg J 2006;26:S28–34.
Jansen DA, Graivier MH. Evaluation of a calcium hydroxylapatite-based implant (Radiesse) for facial soft-tissue augmentation. Plast Reconstr Surg 2006;118(3 Suppl):22S–30S, discussion 1S-3S.
Fulton J, Caperton C. The optimal filler: immediate and long-term results with emulsified silicone (1,000 centistokes) with cross-linked hyaluronic acid. J Drugs Dermatol 2012;11:1336–41.
Ogilvie P, Sattler G, Gaymans F, Belhaouari L, et al. Safe, effective chin and jaw restoration with VYC-25L hyaluronic acid injectable gel. Dermatol Surg 2019;45:1294–303.