Effectiveness and Safety of a High G′ Hyaluronic Acid Injectable for Jawline Definition: A Randomized Controlled Clinical Investigation

BACKGROUND – HASHA is a novel, NASHA HD Technology, hyaluronic acid (HA) injectable, optimized for lower-face shaping. OBJECTIVES – This multicenter study evaluated effectiveness and safety of HASHA 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 HASHA injections (via needle or cannula) or no-treatment control. At Month 12, HASHA-treated subjects were offered optional re-treatment and controls were offered first treatment with HASHA. RESULTS – At Month 3, the HASHA 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 HASHA 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 HASHA-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 – HASHA was superior to no-treatment for improving jawline definition, with improvement lasting throughout 24 months. Subject satisfaction was high. Treatment was well tolerated.