3 Month Evaluation of Hyaluronic Acid Facial Fillers: A Prospective Volumetric Analysis with Patient Reported Outcomes

Harrison Davis, BS, Theodore Habarth-Morales, BS, 1LT, USAR, NRAEMT, Ankoor Talwar, MBA, Abhishek Desai, MD, Phoebe McAuliffe, BS, Robyn Broach, PhD, Joseph Serletti, MD and Ivona Percec, MD, PhD, University of Pennsylvania, Philadelphia, PA
Goals/Purpose: Hyaluronic acid facial fillers are becoming increasingly popular as a less invasive alternative to surgery for treatment of age-related changes. Dermal fillers can reduce signs of aging by restoring facial volume of skin depressions, scars, and by attenuating static and dynamic wrinkles. Although dermal fillers are widely used, there is a lack of literature quantifying the long-term volumetric results or subjective benefit from patient reported outcomes (PROs). This prospective study aimed to determine and compare volumetric changes up to 12 weeks as well as patient reported outcomes.

Methods/Technique: Female patients aged 40 to 65 years old were included. Exclusion criteria consisted of prior injectable dermal filler or surgical facial rejuvenation procedures within the previous 12 months, pregnancy, facial paralysis, congenital asymmetry, or if they were on blood thinner regimens. Subjects were injected in four regions of the face bilaterally using 3 different dermal fillers; Restylane-L® in the nasolabial folds and marionette lines, Restylane-L Lyft® in the malar area (cheek/cheek bone area), and Restylane Silk® in the cutaneous vermillion border. Pre-injection, patients completed 11 independent domains of the FACE-QTM quality of life questionnaire (baseline) and were photographed using 3D Vectra® M3 Imaging Software. Immediate post-intervention and follow ups at 2, 4, and 12 weeks consisted of imaging and FACE-QTM questionnaire completion with an additional satisfaction with outcome domain. Images were subsequently registered in preparation for volumetric analysis with M3 Software (FIGURE). Volumes were reported as difference from pre-injection and from 6 regions: left mid face, left lower face, left lips, right mid face, right lower face, and right lips.

Results/Complications: One hundred and one women were consented. FACE-QTM questionnaire completion was 97.0% at 2 weeks, 92.1% at 4 weeks, and 76.2% at 12 weeks. 3D image capture was 72.4% at 2 weeks, 76.2% at 4 weeks, and 43.6.% at 12 weeks either due to loss of follow up or inadequate image calibration for analysis. Image analysis revealed no significant difference in volume retention of the lower face throughout 12 weeks. The mid face did not show significant decrease in volume retention until 12 weeks. The lips showed significantly decreased volume retention as early as 2 weeks after injection (FIGURE). There was no significant difference in volume loss by laterality. Certain PROs such as facial appearance, nasolabial folds, marionette lines, lips, cheekbones, cheeks, lower face/jawline, psychological function, and social function improved immediately post-injection. The aging score domain improved at 2 weeks. Psychosocial distress worsened immediately post-injection, but improved from baseline by 2 weeks and for the remainder of the study. Satisfaction with outcome worsened significantly from post-injection to 2 weeks (FIGURE).

Conclusion: This study is the largest prospective study of patients undergoing hyaluronic acid facial filler injections that incorporates volumetric analysis with PROs. Our results showed adequate volume maintenance in the mid and lower face throughout 12 weeks, while filler in the lips significantly decreased as early as 2 weeks post injection, possibly due to increased metabolism from increased movement. Surgeons should take this into account when deciding how to distribute filler throughout the face in order to optimize results. The lips were also the only region to receive Restylane Silk®, suggesting that perhaps the optimal filler for this area should be elucidated by future studies. PROs showed improved scores in all FACE-Q domains, aside from satisfaction with outcomes. This was potentially due to injection associated swelling contributing to perceived results that attenuated by 2 weeks. This phenomenon is similar to what is seen immediately after breast augmentation, suggesting it would be appropriate to address this in pre-intervention patient counseling. Our results suggest further investigation into the subjective benefits of dermal filler is warranted due to sustained improvement in various PROs.