PMID- 36387967
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221119
IS  - 1178-7015 (Print)
IS  - 1178-7015 (Electronic)
IS  - 1178-7015 (Linking)
VI  - 15
DP  - 2022
TI  - Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults.
PG  - 2427-2436
LID - 10.2147/CCID.S382194 [doi]
AB  - 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 Juvederm((R)) Volbella((R)) (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.
CI  - (c) 2022 Li et al.
FAU - Li, Dong
AU  - Li D
AD  - Peking University Third Hospital, Beijing, People's Republic of China.
FAU - Gao, Zhanwei
AU  - Gao Z
AD  - Japan Friendship Hospital, Beijing, People's Republic of China.
FAU - Sun, Jiaming
AU  - Sun J
AD  - Union Hospital Tongji Medical College Huazhong University of Science and 
      Technology, Wuhan, People's Republic of China.
FAU - Li, Qin
AU  - Li Q
AD  - General Hospital of Guangzhou Military Command of PLA, Guangzhou, People's 
      Republic of China.
FAU - Jiang, Ping
AU  - Jiang P
AD  - Nanfang Hospital, Southern Medical University, Guangzhou, People's Republic of 
      China.
FAU - Zhang, Lijuan
AU  - Zhang L
AD  - Allergan Aesthetics, an AbbVie Company, Beijing, People's Republic of China.
FAU - Chawla, Smita
AU  - Chawla S
AD  - Clinical Development, Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03519204
PT  - Journal Article
DEP - 20221110
PL  - New Zealand
TA  - Clin Cosmet Investig Dermatol
JT  - Clinical, cosmetic and investigational dermatology
JID - 101543449
PMC - PMC9661899
OTO - NOTNLM
OT  - China
OT  - dermal fillers
OT  - hyaluronic acid
COIS- Lijuan Zhang and Smita Chawla are employees of AbbVie and own AbbVie stock. The 
      authors report no other conflicts of interest in this work.
EDAT- 2022/11/18 06:00
MHDA- 2022/11/18 06:01
PMCR- 2022/11/10
CRDT- 2022/11/17 12:05
PHST- 2022/07/13 00:00 [received]
PHST- 2022/11/04 00:00 [accepted]
PHST- 2022/11/17 12:05 [entrez]
PHST- 2022/11/18 06:00 [pubmed]
PHST- 2022/11/18 06:01 [medline]
PHST- 2022/11/10 00:00 [pmc-release]
AID - 382194 [pii]
AID - 10.2147/CCID.S382194 [doi]
PST - epublish
SO  - Clin Cosmet Investig Dermatol. 2022 Nov 10;15:2427-2436. doi: 
      10.2147/CCID.S382194. eCollection 2022.