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Comparative Trial Evaluating a High- Versus Low-Integration Hyaluronic Acid Filler for Contouring the Jawline
Andreas Nikolis1,2, Kaitlyn M Enright3, Sebastian Cotofana4,5
1Division of Plastic Surgery, McGill University, Montreal, QC, Canada.
Background:
Contour deficits of the jawline are an area of concern for many aesthetic patients. While the use of hyaluronic acid (HA) for jawline enhancement has been described previously, comparative investigations of HA fillers manufactured with different technologies are limited. Therefore, the aim of the current investigation was to evaluate the safety and efficacy of Restylane Lyft (HA-L) and Restylane Defyne (HA-D) for contouring of the jawline.
Methods:
This prospective clinical trial enrolled forty (40) participants. Twenty (20) participants with thin skin were treated with HA-D, and twenty (20) participants with thick skin were treated with HA-L. Visits occurred at Screening/Baseline (treatment), Week 2 (touch-up), and Months 1, 3, and 6. At each visit, a blinded evaluator rated 3-dimensional participant imagery according to the Jawline Volume Loss Scale and participants completed the Jawline Subject Satisfaction Scale. Frequency of treatment-emergent adverse events was collected via participant diaries, and product integration characteristics were evaluated via ultrasound.
Results:
Chi-square tests of independence revealed statistically significant improvements in severities of jawline volume loss, which were maximal at Month 1 (100%) and maintained until Month 6 (82.05%). At Month 1, 92.10% of participants reported being satisfied with overall treatment effects. Adverse events were expected per the product monographs and did not vary per group. On ultrasound, HA-L displayed targeted product integration and HA-D displayed diffuse product integration.
Conclusions:
Results support the use of HA-L and HA-D for the contouring of the jawline with each product capable of providing distinct advantages depending on patient attributes (e.g., skin thickness, underlying bone structure, desired outcomes).
Level Iii:
Evidence obtained from well-designed cohort or case-control analytic studies.
Level Of Evidence Iii:
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
