Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults

Dong Li, Zhanwei Gao, Jiaming Sun, Qin Li, Ping Jiang, Lijuan Zhang, Smita Chawla, Dong Li, Zhanwei Gao, Jiaming Sun, Qin Li, Ping Jiang, Lijuan Zhang, Smita Chawla

Abstract

Background: Hyaluronic acid (HA) soft tissue fillers are used to restore volume loss to the lips and perioral area.

Objective: Evaluate the safety and effectiveness of the HA filler Juvéderm® Volbella® (VYC-15L) for lip enhancement in Chinese adults.

Methods & materials: In this multicenter, evaluator-blind study, subjects seeking lip enhancement were randomized 3:1 to VYC-15L or no-treatment control group (with optional treatment delayed by 3 months). Effectiveness endpoints included 1-point improvement on the 5-point Lip Fullness Scale (LFS) assessed by evaluating investigators (EIs) and subjects, and overall volume of lips and change in lip surface area measured from 3-dimensional images. Safety assessments included procedural pain, injection site reactions (ISRs), and adverse events (AEs).

Results: The modified intention-to-treat population included 163 subjects (median age, 34 years; 96.9% female). More VYC-15L-treated subjects had a 1-point reduction in EI-reported LFS score at month 3 versus untreated controls (84.7% vs 0%; p < 0.0001), and 65% of the treated subjects self-reported a 1-point LFS improvement at month 3. Procedural pain during injection was mild. The most common ISRs were swelling, tenderness to touch, and firmness. One treatment-related serious AE (injection site compression arterial ischemia) resolved in 16 days.

Conclusion: VYC-15L treatment was superior to no treatment at 3 months and was well tolerated by subjects.

Clinical trial registration number: NCT03519204.

Keywords: China; dermal fillers; hyaluronic acid.

Conflict of interest statement

Lijuan Zhang and Smita Chawla are employees of AbbVie and own AbbVie stock. The authors report no other conflicts of interest in this work.

© 2022 Li et al.

Figures

Figure 1
Figure 1
Representative images of 28-year-old female subject before and after VYC-15L treatment. At baseline, the subject had a LFS score of “moderate” as assessed by the EI. The subject was injected with VYC-15L in the upper lip (0.6 mL), lower lip (0.5 mL), and philtral column (0.4 mL) at initial treatment (subject did not receive touch-up treatment). Three months after treatment, the subject had an EI-assessed LFS score of “marked.” This patient has provided written consent to publish her images and details.
Figure 2
Figure 2
Mean change in lip volume (cm3) (A) and percentage change in lip surface area (B) from baseline to months 1, 3, and 6 (mITT population). No-treatment control group subjects were not assessed at month 6.
Figure 3
Figure 3
EI- and subject-assessed GAIS responder rates (mITT population). For the EI-assessed responder rates (A), untreated control subjects were not evaluated at month 6. For the subject-assessed responder rates (B), untreated control subjects were not evaluated.

References

    1. Wollina U. Perioral rejuvenation: restoration of attractiveness in aging females by minimally invasive procedures. Clin Interv Aging. 2013;8:1149–1155. doi:10.2147/CIA.S48102
    1. Samizadeh S, Wu W. Ideals of facial beauty amongst the Chinese population: results from a large national survey. Aesthetic Plast Surg. 2018;42(6):1540–1550. doi:10.1007/s00266-018-1188-9
    1. Ponsky D, Guyuron B. Comprehensive surgical aesthetic enhancement and rejuvenation of the perioral region. Aesthet Surg J. 2011;31(4):382–391. doi:10.1177/1090820X11409009
    1. Ali MJ, Ende K, Maas CS. Perioral rejuvenation and lip augmentation. Facial Plast Surg Clin North Am. 2007;15(4):491–500, vii. doi:10.1016/j.fsc.2007.08.008
    1. Gassia V, Raspaldo H, Niforos FR, Michaud T. Global 3-dimensional approach to natural rejuvenation: recommendations for perioral, nose, and ear rejuvenation. J Cosmet Dermatol. 2013;12(2):123–136. doi:10.1111/jocd.12035
    1. Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009;8(3):205–210. doi:10.1111/j.1473-2165.2009.00451.x
    1. Goodman GJ, Swift A, Remington BK. Current concepts in the use of Voluma, Volift, and Volbella. Plast Reconstr Surg. 2015;136(5 Suppl):139S–148S. doi:10.1097/PRS.0000000000001734
    1. Eccleston D, Murphy DK. Juvéderm (R) Volbella in the perioral area: a 12-month prospective, multicenter, open-label study. Clin Cosmet Investig Dermatol. 2012;5:167–172. doi:10.2147/CCID.S35800
    1. Borrell M, Leslie DB, Tezel A. Lift capabilities of hyaluronic acid fillers. J Cosmet Laser Ther. 2011;13(1):21–27. doi:10.3109/14764172.2011.552609
    1. Smith L, Cockerham K. Hyaluronic acid dermal fillers: can adjunctive lidocaine improve patient satisfaction without decreasing efficacy or duration? Patient Prefer Adherence. 2011;5:133–139. doi:10.2147/PPA.S11251
    1. Geronemus RG, Bank DE, Hardas B, Shamban A, Weichman BM, Murphy DK. Safety and effectiveness of VYC-15L, a hyaluronic acid filler for lip and perioral enhancement: one-year results from a randomized, controlled study. Dermatol Surg. 2017;43(3):396–404. doi:10.1097/DSS.0000000000001035
    1. Philipp-Dormston WG, Hilton S, Nathan M. A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips. J Cosmet Dermatol. 2014;13(2):125–134. doi:10.1111/jocd.12085
    1. Raspaldo H, Chantrey J, Belhaouari L, et al. Lip and perioral enhancement: a 12-month prospective, randomized, controlled study. J Drugs Dermatol. 2015;14(12):1444–1452.
    1. Raspaldo H, Chantrey J, Belhaouari L, Saleh R, Murphy DK. Juvéderm Volbella with Lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open. 2015;3(3):e321. doi:10.1097/GOX.0000000000000266
    1. Rivkin A, Weinkle SH, Hardas B, et al. Safety and effectiveness of repeat treatment with VYC-15L for lip and perioral enhancement: results from a prospective multicenter study. Aesthet Surg J. 2019;39(4):413–422. doi:10.1093/asj/sjy019
    1. Liew S, Wu WT, Chan HH, et al. Consensus on changing trends, attitudes, and concepts of Asian beauty. Aesthetic Plast Surg. 2016;40(2):193–201. doi:10.1007/s00266-015-0562-0
    1. Werschler WP, Fagien S, Thomas J, Paradkar-Mitragotri D, Rotunda A, Beddingfield FC. Development and validation of a photographic scale for assessment of lip fullness. Aesthet Surg J. 2015;35(3):294–307. doi:10.1093/asj/sju025
    1. Dayan S, Bruce S, Kilmer S, et al. Safety and effectiveness of the hyaluronic acid filler, HYC-24L, for lip and perioral augmentation. Dermatol Surg. 2015;41(suppl1):S293–S301. doi:10.1097/DSS.0000000000000540
    1. Restylane Silk [instructions for use]. Fort Worth, TX, USA: Galderma Laboratories, L.P; 2017.
    1. Beer K, Glogau RG, Dover JS, et al. A randomized, evaluator-blinded, controlled study of effectiveness and safety of small particle hyaluronic acid plus lidocaine for lip augmentation and perioral rhytides. Dermatol Surg. 2015;41(Suppl 1):S127–S136. doi:10.1097/DSS.0000000000000199

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj