Objectives: The lower face is a significant aspect of the overall facial structure, reflecting the physiognomic characteristics of an individual, with the chin contour being a primary
factor influencing facial aesthetics.
As individuals age, the lower face undergoes gradual aging, leading to the appearance of skin laxity and subcutaneous tissue relaxation[1-3].
Chin augmentation using cross-linked hyaluronic acid(HA) injectables can effectively enhance facial appearance.
Introduction: In both men and women, having a well-defined chin is widely regarded as a hallmark of beauty and can significantly impact an individual's psychological and social well-being.
Ideally, the height of the chin should constitute around two-thirds of the lower facial area, and its projection should align with the pogonion meeting the perpendicular line from the nasion[4].
Hyaluronic acid (HA) injections have been extensively used for over a decade to augment chins and rejuvenate facial appearance, with a well-established track record of safety and efficacy[5-7].
Materials / method: This is a prospective, multicenter, randomized, no-treatment controlled, investigator blinded, superiority clinical trial (ChiCTR2200063817).
Between September 2022 to January 2024, 159 subjects with chin retrusion were randomized (2?1) in the test group (n=106) and in the no-treatment control group (n=53).
Response rate of chin augmentation at different visits ( at 6 month as assessed by third party independent investigators and at 1,3,6,9, 12 month as assessed by injection investigators) and GAIS scores as assessed by subjects were evaluated as efficacy endpoints.
Results: Response rates of chin augmentation improvement at 6 month (assessed by third-party independent blinded investigators)
Response rate of chin augmentation improvement in test group at 6 month after the last injection (assessed by a third-party independent blinded investigator) were 64.2%(95%Cl: 55.0%, 73.3%) , while in the control group were 20.8%(95%Cl: 9.8%, 31.7%) . The treatment was effective.
Response rates of chin augmentation improvement (assessed by injection investigators)
The test group exhibited a significantly higher improvement rate in chin augmentation compared to the control
Conclusion: Our findings suggest that the test medical device(MaiLi-E) was significantly more efficacious than the control group in chin augmentation at 1,3, and 6 month after treatment, and the test device efficacy maintained up to 12 month after treatment.
Additionally, the GAIS scores of subjects in the test group were significantly lower(better) than those in the control group at 1, 3, and 6 month following the last injection.
During the clinical trial, the test group was equivalent to the control group in terms of the incidences of various AEs, without device defects reported.
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