Abstract / Summary
BACKGROUND HA SHA is a novel, NASHA HD Technology, hyaluronic acid (HA) injectable, optimized for lower-face shaping. OBJECTIVES This multicenter study evaluated effectiveness and safety of HA SHA in improving jawline definition for up to 2 years. METHODS Subjects with moderate-to-very-severe volume deficiency on the Galderma Jawline Scale (GJS) were randomized 3:1 to HA SHA injections (via needle or cannula) or no-treatment control. At Month 12, HA SHA -treated subjects were offered optional re-treatment and controls were offered first treatment with HA SHA . RESULTS At Month 3, the HA SHA group ( N = 168) had a statistically significant ( p < .001) higher ≥1-grade blinded evaluator-assessed GJS responder rate than the no-treatment group ( N = 68) (85.1% vs 14.3%, primary endpoint), which remained high in the HA SHA group at Months 12 (67.1%) and 24 (69.0% without re-treatment; 81.3% with Month-12 re-treatment). Treating-investigator-assessed Global Aesthetic Improvement Scale improvement rates were ≥84% at Months 3 to 24. Most HA SHA -treated subjects reported improved overall satisfaction with their appearance (≥70%) and natural-looking results (≥82%) through Month 24. Treatment-related adverse events, all mild or moderate, occurred in 14.5% of subjects after initial treatment. CONCLUSION HA SHA was superior to no-treatment for improving jawline definition, with improvement lasting throughout 24 months. Subject satisfaction was high. Treatment was well tolerated.