VYC-17.5 L Can Improve Marionette Lines, According to Recent Study

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A 12-month clinical trial tested the efficacy and safety of VYC-17.5 L in treating marionette lines on the lower third of the face.¹ After just 1 month of treatment, high investigator and participant satisfaction ratings were observed.

Juvederm VOLIFT with lidocaine, containing 17.5 mL of hyaluronic acid and 3 mg/mL of lidocaine, is known for its moderate lift capacity and good tissue integration when treating other skin depressions associated with premature aging.²

The prospective, open-label, single-group, post-marketing study took place at a singular site in France from September 2021 to November 2022. Qualifying participants were 18 years and older and had mild-to-severe marionette lines at Grades 1-4, according to the Allergan Marionette Line Scale (AMLS). Nearly all 78 patients were female (95.2%) with a mean age of 59.2 years.

Treatment was given on day 1 with optional touch-ups offered on day 14, which was utilized by 54 patients. Clinicians used a combination of fanning and linear threading techniques, with a maximum volume of 2 mL for each marionette line. The average injection volume was 0.73 mL for the initial treatment and 0.35 mL for the touch-up. In total, 7 visits occurred, including screening and follow-ups after 1, 3, 6, 9, and 12 months.

The primary endpoint was the proportion of participants with a ≥ 1-point change in AMLS from baseline after 1 month. The secondary endpoint was the same rate of change but reported at months 3, 6, 9, and 12. Researchers also recorded results using the 5-point Global Aesthetic Improvement Scale (GAIS) and FACE-Q satisfaction questionnaire. Photographs were also taken as a form of measurement. In terms of safety, the incidence and severity of adverse events were monitored throughout the entire 12-month study.

69.9% of participants had ≥ 1-point change in AMLS with improvement in GAIS, according to both the investigators and the participants. A decline in response was observed at months 3 (58.2%) and 6 (51.3%). This continued through month 12. Additionally, both FACE-Q scores significantly improved from baseline, with a mean change of 18.1 (p < 0.0001). This decreased over time to 10.9 at month 12. 

By month 1, participants were very satisfied with the balance, freshness, and proportionality of their faces. Nearly 99% of patients achieved a GAIS rating of “improved” or “much improved”, as measured by investigators and participants at month 1. This rating slowly declined to 50% at subsequent follow-up visits over the year. Significant volume improvements were observed as well at month 1 compared to baseline (0.80 and 0.76, respectively; p < 0.0001). Starting at month 3, these began to trend downward.

“It is worth noting that based on the validated AMLS, not all patients may need a 1-point improvement of their marionette lines,” the authors wrote. “Some participants in the study did not achieve the primary endpoint (i.e., a 1-point improvement on the AMLS) but were still satisfied with the treatment based on the patient-reported GAIS and FACE-Q satisfaction ratings. Thus, even small improvements in the appearance of marionette lines may result in high patient satisfaction.”

In terms of adverse events, mild to moderate local injection site reactions were observed, including pain and tenderness, swelling, lumps, redness, bruising, itching, and discoloration. Pain was the most frequently reported and was experienced by 80% of participants. All of these resolved within 8 days or less and no serious effects were reported.

There were some limitations in the study, as noted by its authors. There was a lack of participant diversity, specifically in regard to gender and Fitzpatrick skin phototype. This may limit the generalizability of the results.

Currently, the most common approach to treating marionette lines is hyaluronic acid dermal fillers. Prior to this study, there was little to no research on VYC-17.5 L ‘s efficacy and safety in the treatment of marionette lines.

References

1. Cueto SRD, Urdiales Galvez F, Gritti A, Kefalas N, de la Guardia C, Kerson G. An Evaluation of VYC-17.5L for the Treatment of Marionette Lines: A Prospective, Open-Label, Postmarketing Study. J Cosmet Dermatol. Published online November 27, 2024. doi:10.1111/jocd.16694

2. Sattler G, Philipp-Dormston WG, Van Den Elzen H, et al. A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months. Dermatol Surg. 2017;43(2):238-245. doi:10.1097/DSS.0000000000000939