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Dermatol Surg. 2017 Mar;43(3):396-404. doi: 10.1097/DSS.0000000000001035.

Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study.

Author information

1
*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.

Abstract

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.

CONCLUSION:

VYC-15L was safe and effective for lip and perioral enhancement, with treatment effects lasting through 1 year.

PMID:
28157728
DOI:
10.1097/DSS.0000000000001035
[Indexed for MEDLINE]

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