Lip Augmentation With Saypha LIPS Lidocaine: A Postmarket, Prospective, Open-Label, Randomized Clinical Study To Evaluate Its Efficacy and Short- and Long-term Safety

Summary: This multicenter study assessed the effectiveness and safety of Saypha LIPS Lidocaine in 114 patients with moderate to severe lip volume loss. At six weeks post injection, over 90% of participants saw at least a one‑grade improvement in lip fullness, with results influenced by baseline deficiency and injection volume but not by optional touch‑ups. Durability was strong: 90% maintained improvement at 6 months, 70% at 1 year, and more than 40% still showed visible enhancement at 18 months. Treatment‑related side effects were generally mild, brief, and procedural in nature, and most patients reported high satisfaction and low pain levels shortly after treatment. This study concluded that Saypha LIPS Lidocaine was found to be effective and safe for lip augmentation in this cohort of 114 patients.

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