Efficacy and Safety of Chin Augmentation Using MaiLi-E, a Lidocaine-Containing Cross-Linked Sodium Hyaluronate Gel

Abstract

Background: MaiLi-E is a lidocaine-containing cross-linked sodium hyaluronate gel for dermal filling. This prospective, multicenter, randomized, delayed-treatment controlled, evaluator-blinded clinical trial aims to evaluate the efficacy and safety of MaiLi-E for chin augmentation. Methods: Participants with mild-to-moderate–severe chin retrusion were enrolled and randomized (2:1) to receive MaiLi-E at study onset (MaiLi-E group) or six months later (control group). The primary efficacy endpoint was the response rate of chin retrusion improvement, defined as the percentage of participants whose China (Allergan) Chin Retrusion Scale score improved by ≥1 point from baseline, assessed by independent investigators at Month 6 post-injection for the MaiLi-E group and Month 6 post-randomization for the control group. Safety assessments included adverse events (AEs) and treatment-related AEs. Results: Between September 2022 and January 2023, 159 participants were enrolled (MaiLi-E group, n = 106; control group, n = 53). Response rates of chin retrusion improvement were 64.2% (95% CI 55.0–73.3%) in the MaiLi-E group and 20.8% (95% CI 9.8–31.7%) in the control group (P < 0.0001). Improvement rates of the Global Aesthetic Improvement Scale evaluated by participants were 91.5% (95% CI 86.2–96.8%) in the MaiLi-E group and 0.0% (95% CI 0.0–0.0%) in the control group. Response was maintained in most participants at Month 12 post-treatment. Participant satisfaction rates were 72.6% in the MaiLi-E and 74.5% in the control group. 64.8% of participants experienced AEs, and 5.0% experienced treatment-related AEs from the initial treatment to Month 6 after the last injection. Conclusion: MaiLi-E is effective and safe in correcting mild-to-moderate–severe chin retrusion. Evidence obtained from at least one properly designed randomized controlled trial. Level of Evidence I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.