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Aesthet Surg J. 2018 Jan 30. doi: 10.1093/asj/sjy019. [Epub ahead of print]

Safety and Effectiveness of Repeat Treatment With VYC-15L for Lip and Perioral Enhancement: Results From a Prospective Multicenter Study.

Author information

David Geffen/UCLA School of Medicine, Los Angeles, CA.
Dermatology, University of South Florida, Tampa, FL.
Allergan plc (Irvine, CA) at the time of manuscript preparation.
Department of Dermatology, University of Maryland School of Medicine, Baltimore, MD.
Department of Dermatology, Saint Louis University, St. Louis, MO.
Centre for Laser and Facial Surgery, Vanderbilt University School of Medicine, Nashville, TN.
Clinical Development at Allergan plc.



VYC-15L (Juvéderm Volbella XC) is a non-animal crosslinked hyaluronic acid (HA) gel with lidocaine.


To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement.


In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment.


LFS responder rates were 86.2%, 80.3%, and 61.8% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touchup treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment.


Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.


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