A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months

Abstract

Background: VYC-17.5L (17.5 mg/mL hyaluronic acid, 0.3% lidocaine) is a dermal filler intended for deep dermis injection for the treatment of skin depressions.

Objective: To evaluate 12-month effectiveness and safety of VYC-17.5L for the treatment of moderate/severe nasolabial folds (NLFs).

Methods: Subjects ≥18 years old with moderate/severe NLFs were recruited (N = 70). Injected volume was aimed at achieving optimum correction; top-up treatment was given at 2 weeks if needed. The primary endpoint was investigator-assessed change in NLF severity over 12 months using the validated photonumeric NLF Severity Scale. Secondary endpoints included investigator- and subject-assessed satisfaction and safety. Adverse events judged to be more severe or prolonged than routinely observed were recorded.

Results: Sixty-five subjects completed study requirements. Mean volume injected was 3.0 ± 1.0 mL for both NLFs combined. Significant improvement was maintained in investigator-assessed NLF severity at 12 months, and investigators and subjects reported high satisfaction with VYC-17.5L throughout the study. Two unexpected adverse events were reported: (1) redness, swelling, and decreased sensitivity (resolved after 4 days) and (2) swelling (resolved after 48 hours); neither event was serious or life threatening.

Conclusion: VYC-17.5L is effective and well tolerated for the treatment of moderate to severe NLFs for 1 year.

Figures

Figure 1.

Participant flow chart.

Figure 2.

Mean investigator-assessed NLF severity by time point for right and left NLFs. Significant differences between baseline and each time point are shown (p < .001***). NLF, nasolabial fold.

Figure 3.

Subject satisfaction mean scores stratified by time point. Significant differences were assessed between baseline and each time point as appropriate (p < .05*, p < .01**, p < .001***).