PMID- 34743118
OWN - NLM
STAT- MEDLINE
DCOM- 20220113
LR  - 20230814
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Print)
IS  - 1076-0512 (Linking)
VI  - 47
IP  - 12
DP  - 2021 Dec 1
TI  - Safety and Effectiveness of Hyaluronic Acid Filler, VYC-20L, via Cannula for 
      Cheek Augmentation: A Randomized, Single-Blind, Controlled Study.
PG  - 1590-1594
LID - 10.1097/DSS.0000000000003246 [doi]
AB  - BACKGROUND: Using cannulas to deliver facial fillers may reduce adverse events 
      (AEs) compared with needle injection. OBJECTIVE: To evaluate the safety and 
      effectiveness of VYC-20L (20 mg/mL hyaluronic acid gel with lidocaine) via 
      cannula for midface age-related volume deficit. MATERIALS AND METHODS: This 
      multicenter, evaluator-blind, randomized, within-subject, controlled study 
      enrolled adults with moderate to severe Mid-Face Volume Deficit Scale (MFVDS) 
      scores. VYC-20L was administered in one cheek via cannula (with optional needle 
      use in the zygomaticomalar region) and in the other cheek via needle. The primary 
      effectiveness end point was the mean (95% confidence interval [CI]) paired 
      difference between treatments in MFVDS score change from baseline to Month 1; an 
      upper CI limit of less than 0.5 determined noninferiority. Injection-site 
      responses (ISRs), procedural pain, and AEs were assessed. RESULTS: Of 60 
      randomized and treated subjects, the mean change in MFVDS score from baseline to 
      Month 1 was -1.8 with cannulas and -1.9 with needles, providing a mean (95% CI) 
      paired difference of 0.1 (-0.05 to 0.25). Most ISRs were mild/moderate and 
      resolved within 2 weeks. Procedural pain was minimal, and no serious AEs were 
      reported. CONCLUSION: VYC-20L for cheek augmentation was safe and effective using 
      a cannula and noninferior to needle injection.
CI  - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the American Society for Dermatologic Surgery, Inc.
FAU - Jones, Derek
AU  - Jones D
AD  - Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California.
FAU - Palm, Melanie
AU  - Palm M
AD  - Art of Skin MD, Solana Beach, California.
FAU - Cox, Sue Ellen
AU  - Cox SE
AD  - Aesthetic Solutions, Chapel Hill, North Carolina.
FAU - McDermott, Michelle
AU  - McDermott M
AD  - Peloton Advantage, LLC, Parsippany, New Jersey.
FAU - Sartor, Marta
AU  - Sartor M
AD  - Allergan Aesthetics, an AbbVie Company, Irvine, California.
FAU - Chawla, Smita
AU  - Chawla S
AD  - Allergan Aesthetics, an AbbVie Company, 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  - 9004-61-9 (Hyaluronic Acid)
RN  - 98PI200987 (Lidocaine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cannula
MH  - *Cheek
MH  - Cosmetic Techniques
MH  - Dermal Fillers/*administration & dosage
MH  - Female
MH  - Humans
MH  - Hyaluronic Acid/*administration & dosage
MH  - Lidocaine/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Single-Blind Method
PMC - PMC8612896
EDAT- 2021/11/08 06:00
MHDA- 2022/01/14 06:00
PMCR- 2021/11/25
CRDT- 2021/11/07 20:43
PHST- 2021/11/08 06:00 [pubmed]
PHST- 2022/01/14 06:00 [medline]
PHST- 2021/11/07 20:43 [entrez]
PHST- 2021/11/25 00:00 [pmc-release]
AID - 00042728-202112000-00012 [pii]
AID - ds-00994-2019 [pii]
AID - 10.1097/DSS.0000000000003246 [doi]
PST - ppublish
SO  - Dermatol Surg. 2021 Dec 1;47(12):1590-1594. doi: 10.1097/DSS.0000000000003246.