Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study.
BACKGROUND
VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine.


OBJECTIVE
To evaluate the safety and effectiveness of VYC-15L for lip and perioral enhancement versus a nonanimal stabilized HA with lidocaine (Restylane-L; NASHA).


METHODS
This prospective multicenter study randomized 225 adults with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) to treatment with VYC-15L or NASHA; optional touch-up was administered 30 days later. Subjects were followed for 1 year. The primary effectiveness end point was noninferiority of VYC-15L versus NASHA by mean change in LFS score from baseline to Month 3.


RESULTS
The primary end point was met. At Month 3, LFS responder rates were 80.3% for VYC-15L versus 70.8% for NASHA. LFS responder rates exceeded 60% through 1 year with VYC-15L. Perioral lines severity improved for 65.4% and 66.2% of VYC-15L subjects at Month 3 and Year 1, respectively. At Month 3, 96.1% and 88.2% of subjects reported improvement in FACE-Q Satisfaction With Lips and Satisfaction With Lip Lines, respectively. Severe injection site responses were reported less frequently with VYC-15L than NASHA.


CONCLUSIONS
VYC-15L was safe and effective for lip and perioral enhancement, with treatment effects lasting through 1 year.
*Laser & Skin Surgery Center of New York, New York, New York; †The Center for Dermatology, Cosmetic & Laser Surgery, Mt. Kisco, New York; ‡Allergan plc, Irvine, California; §AVA MD, Santa Monica, California; ‖BMW Associates, Monroe Township, New Jersey.
Roy G
RG
Geronemus
David E
DE
Bank
Bhushan
B
Hardas
Ava
A
Shamban
Barry M
BM
Weichman
Diane K
DK
Murphy
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007271:Injections, Intradermal; D008046:Lip / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012060:Rejuvenation; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome; D014481:United States; D055675:Viscosupplements / Q000008:administration & dosage*
D055675:Viscosupplements; D006820:Hyaluronic Acid