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Randomized Controlled Trial
. 2021 Jan 1;47(1):80-85.
doi: 10.1097/DSS.0000000000002795.

Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L

Kenneth Beer  1 , Joely Kaufman-Janette  2 , David Bank  3 , Brian Biesman  4 , Steven Dayan  5 , William Kim  6 , Smita Chawla  6 , Andrew Schumacher  6
Affiliations
Randomized Controlled Trial

Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L

Kenneth Beer et al. Dermatol Surg. .

Abstract

Background: VYC-20L is a hyaluronic acid soft tissue filler with lidocaine designed to restore facial volume.

Objective: Evaluate the safety and effectiveness of VYC-20L in patients with chin retrusion.

Materials and methods: Adults with chin retrusion were randomized (3:1) to receive VYC-20L in the chin at study onset (treatment group) or 6 months later (control group). The primary effectiveness end point was ≥1-point improvement on the Allergan Chin Retrusion Scale (ACRS) from baseline at Month 6. Safety assessments included injection site responses (ISRs) and adverse events (AEs).

Results: VYC-20L was administered to 192 participants (treatment group, n = 144; control group, n = 48). At Month 6, significantly more participants had an ACRS response in the treatment versus control group (56.3% vs 27.5%; p = .0019). Effectiveness was also demonstrated by the proportion of participants with improved/much improved Global Aesthetic Improvement Scale scores and responses on the FACE-Q Satisfaction with Chin questionnaire and FACE-Q Psychological Wellbeing module. Treatment benefit remained evident at Month 12. Most common ISRs were tenderness (81.1%) and firmness (75.1%). One participant (0.5%) discontinued the study due to 2 treatment-related serious AEs of facial cellulitis and injection site inflammation, both resolved without sequelae.

Conclusion: VYC-20L significantly improved an ACRS response and was generally safe and well tolerated.

Trial registration: ClinicalTrials.gov NCT02833077.

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Conflict of interest statement

This study was sponsored by Allergan plc, Dublin, Ireland. Medical writing assistance was provided to the authors by W. Kim of Allergan plc, Irvine, CA. All authors met the ICMJE authorship criteria. Neither honoraria nor any other form of compensation was provided for authorship. K. Beer, J. Kaufman-Janette, D. Bank, and S. Dayan have received funding as an investigator, consultant, and trainer for Allergan. B. Biesman has received consulting fees and research funding from Allergan. W. Kim, S. Chawla, and A. Schumacher are employees of Allergan plc and may own stock in the company.

Comment in

References

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