Aesthetic Improvement, Facial Harmony, and Patient Satisfaction after Lower Face Treatment with a Hyaluronic Acid Filler: A Randomized Post-Marketing Study to Evaluate Two Different Stepwise Injection Approaches.

[OBJECTIVE] The authors sought to evaluate a flexible, hyaluronic acid (HA) filler, Restylane® Defyne™ (HA) (Galderma), for combined treatment of chin, nasolabial folds (NLFs), and marionette lines (MLs), in a predefined stepwise order, comparing Down-up (ie, chin first) versus Top-down (NLFs and MLs first) treatment approaches. This postmarketing study complements prior pivotal investigations that demonstrated the safety and effectiveness of HA treatments of the lower face, by providing a standardized treatment algorithm for combining several treatment areas in the lower face.

[METHODS] HA was injected at Day 1 in the first treatment area and at Week 3 in the second area (randomized to either Down-up or Top-down order), with optional touch-up (any area) at Week 6. Assessments included Global Aesthetic Improvement Scale (GAIS), skin firmness, facial harmony, patient satisfaction, and safety until Week 9.

[RESULTS] Both approaches achieved similar, favorable results at Week 9, with 100% of patients in both groups (Down-up, n=31; Top-down, n=29) demonstrating aesthetic improvement on the GAIS, improved skin firmness and facial harmony, and natural-looking results. Of patients seeking aesthetic improvement of the submental area, 95% in the Top-down group and 100% in the Down-up achieved improvement. Patient-reported endpoints supported these results, with high satisfaction throughout the study. HA was well tolerated throughout the study.

[LIMITATIONS] The results should be considered indicative rather than definitive given the post-marketing design of the study.

[CONCLUSION] Both stepwise approaches may be used for administering HA when treating the combined areas of chin, NLFs, and MLs.