J Drugs Dermatol. 2024 Apr 1;23(4):255-261. doi: 10.36849/JDD.8145.
A hyaluronic acid (HA) filler intended for non-surgical improvement of chin appearance should ideally be of high strength/firmness (high G') to allow for deep injections on the bone. HASHA (Restylane Shaype) is a new hyaluronic acid (HA) injectable with high G' and high HA concentration (25 mg/mL), engineered by the new NASHA-HD (High Definition) technology. HASHA is suitable to be placed periosteally, aiming to mimic the natural shape of the bony chin. This pivotal clinical investigation evaluated effectiveness and safety of HASHA for augmentation and correction of chin retrusion. Methods: Subjects 18 years or older with mild or moderate chin retrusion by the Galderma Chin Retrusion Scale (GCRS), were randomized 3:1 to HASHA (n=103) or no treatment (n=37). Assessments included GCRS (blinded evaluator), aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), subject satisfaction, and safety. Results: GCRS responder rate (1-grade or greater improvement from baseline) was significantly higher for HASHA (83.3%) versus controls (10.8%) at month 3 (P<0.001) and maintained through month 12 (P<0.001). Aesthetic improvement was high throughout the study in the HASHA group, according to investigators (97% or greater) and subjects (89% or greater). Overall, subject satisfaction was high at month 3 and maintained at month 12. Product- or injection-related adverse events were mostly mild or moderate and transient. No product- or injection-related serious adverse events were reported.
HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months. J Drugs Dermatol. 2024;23(4):255-261. doi:10.36849/JDD.8145.
一种用于非手术改善颏部外观的透明质酸（HA）填充剂，理想情况下应具有高强度/硬度（高 G'），以便在骨头上进行深层注射。HASHA（瑞蓝·颏部塑形）是一种新型透明质酸（HA）注射剂，具有高 G'和高 HA 浓度（25mg/ml），采用新型 NASHA-HD（高清晰度）技术制造。HASHA 适合放置在骨膜下，旨在模仿骨性颏部的自然形状。这项关键性临床研究评估了 HASHA 用于颏部后缩矫正和填充的有效性和安全性。
18 岁或以上，Galderma 颏部后缩量表（GCRS）评估为轻度或中度颏部后缩的受试者，按 3：1 随机分为 HASHA（n=103）或对照组（n=37）。评估包括 GCRS（盲法评估者）、美学改善（整体美学改善量表 [GAIS]）、受试者满意度和安全性。
HASHA 组在第 3 个月（P<0.001）和第 12 个月（P<0.001）时的 GCRS 应答率（较基线改善 1 级或以上）显著高于对照组（10.8%）。在整个研究过程中，根据研究者（97%或更高）和受试者（89%或更高）的评估，HASHA 组的美学改善均较高。总体而言，第 3 个月时受试者满意度较高，并在第 12 个月时保持。产品或注射相关的不良事件大多为轻度或中度，且为一过性。未报告与产品或注射相关的严重不良事件。
HASHA 是一种新型的 NASHA-HD 注射剂，具有额外的强度/硬度，用于颏部填充和矫正颏部后缩是安全有效的，12 个月时具有较高的美学改善和受试者满意度。J 皮肤病药物学杂志。2024;23(4):255-261.
