A Phase III Clinical Study of the Efficacy and Safety of Botulinum Toxin Type A (MASPORT) with DYSPORT for the Treatment of Glabellar Lines,Aesthetic Plastic Surgery

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A Phase III Clinical Study of the Efficacy and Safety of Botulinum Toxin Type A (MASPORT) with DYSPORT for the Treatment of Glabellar Lines
Aesthetic Plastic Surgery ( IF 2.0 ) Pub Date : 2024-01-17 , DOI: 10.1007/s00266-023-03766-5
Kamand Hedayat ₁ , Amir H Ehsani ₂

Affiliation

Background

Botulinum toxin type A is a widely used treatment of facial wrinkles. The objective of this study was to compare the efficacy and safety of a new botulinum toxin type A (Masport [abobotulinum toxin A], MasoonDarou Co) with DYSPORT^® for the treatment of glabellar lines.

Methods

262 subjects with moderate-to-severe glabellar lines received either a fixed dose of 50 units of MASPORT^® or DYSPORT^® (Ipsen Company, England). Subjects were followed up at 14, 30, 60, 90 and 120 days after injection. Efficacy was assessed by investigator at maximum frown and rest and also by Subject Global Assessment of Change (SGA). The responders were defined as persons with +2 grade improvement from baseline for both investigator and patient assessment. The occurrence and duration of adverse effects were recorded up throughout the study.

Results

According to the investigator evaluations, the responder rate at maximum frown were 94.5% for MASPORT and 95.6% for DYSPORT group on day 30 and at rest were 85.45% and 85.68% for MASPORT and DYSPORT group, respectively. According to the subject self-assessment, the proportion of responders in MASPORT group at day 30 was 95.28% versus 97.04% for DYSPORT group. No serious drug related adverse effect was recorded in either study groups, and the rates of adverse effects were similar for both groups.

Conclusion

Abobotulinum toxin A [MASPORT] is equally safe and effective as commercial product [DYSPORT] for the treatment of glabellar lines with the dose of 50 units, up to 120 days.

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.

中文翻译：

A 型肉毒杆菌毒素 (MASPORT) 联合 DYSPORT 治疗眉间纹疗效和安全性的 III 期临床研究

背景

A 型肉毒杆菌毒素广泛用于治疗面部皱纹。本研究的目的是比较新型 A 型肉毒杆菌毒素（Masport [abobotulinum toxin A], MasoonDarou Co）与 DYSPORT ^®治疗眉间纹的功效和安全性。

方法

262 名患有中度至重度眉间纹的受试者接受了固定剂量的 50 单位 MASPORT ^®或 DYSPORT ^® （Ipsen Company，英国）。注射后14、30、60、90和120天对受试者进行随访。研究者在最大限度地皱眉和休息时以及受试者总体变化评估（SGA）来评估疗效。响应者被定义为在研究者和患者评估方面较基线有 +2 级改善的人。在整个研究过程中记录不良反应的发生和持续时间。

结果

根据研究者评估，第30天时，MASPORT和DYSPORT组最大皱眉时的反应率为94.5%，DYSPORT组为95.6%，休息时MASPORT和DYSPORT组的反应率分别为85.45%和85.68%。根据受试者自我评估，第 30 天时 MASPORT 组有反应的比例为 95.28%，而 DYSPORT 组有反应的比例为 97.04%。两个研究组均未记录到严重的药物相关不良反应，且两组的不良反应发生率相似。