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衡力肉毒毒素 A 治疗颈阔肌带:一项单臂、前瞻性概念验证临床研究。

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study.

机构信息

*Prager and Partner, Derma-Hamburg, Hamburg, Germany; †Praxis für Dermatologie, Hautarztpraxis Stengel and Bee, Munster, Germany; ‡SCIderm GmbH, Hamburg, Germany.

出版信息

Dermatol Surg. 2015 Jan;41 Suppl 1:S88-92. doi: 10.1097/DSS.0000000000000177.

Abstract

BACKGROUND

IncobotulinumtoxinA improves the appearance of facial rhytides and the aging neck.

OBJECTIVE

To investigate the efficacy, safety, and subject satisfaction of incobotulinumtoxinA for platysmal band treatment.

METHODS

Subjects (n = 23) with 2 to 4 platysmal bands (scoring ≥1 on a newly validated 5-point assessment scale) were enrolled. IncobotulinumtoxinA (15 U) was administered to each band. Assessments, using the 5-point scale, occurred at 6 posttreatment visits over 5 months. Adverse events were recorded and subjects self-assessed the appearance of their platysmal bands versus baseline.

RESULTS

At maximum tension, a response (≥1-point improvement from baseline score) was observed in 65.2% of subjects 3 (±1) days posttreatment, rising to 100% on Day 8 (±1). The change from baseline in the mean score was significant at each time point, including the final visit (Weeks 20-21). Response rates were higher at maximum tension than at rest. The peak effect occurred later at rest than at maximum tension. No serious adverse event occurred. At maximum tension, 69.6%, 73.9%, and 68.2% of subjects rated their platysmal bands as "improved" or "markedly improved" at Visits 2, 3, and 4, respectively.

CONCLUSION

IncobotulinumtoxinA is an effective and well-tolerated treatment for platysmal bands, with a rapid onset and long duration of effect.

摘要

背景

IncobotulinumtoxinA 可改善面部皱纹和衰老颈部的外观。

目的

研究 IncobotulinumtoxinA 治疗颈阔肌带的疗效、安全性和患者满意度。

方法

纳入 23 例颈阔肌带 2-4 条(新验证的 5 分评估量表评分≥1)的受试者。每条带给予 IncobotulinumtoxinA(15U)。在 5 个月的 6 次治疗后访视中,使用 5 分制进行评估。记录不良事件,并由受试者自我评估颈阔肌带相对于基线的外观。

结果

在最大张力时,65.2%的受试者在治疗后 3(±1)天出现反应(与基线评分相比≥1 分改善),在第 8 天(±1)时上升至 100%。在每个时间点,包括最后一次访视(第 20-21 周),从基线的平均评分变化均具有统计学意义。在最大张力时的反应率高于在休息时。在休息时的峰值效果晚于在最大张力时。未发生严重不良事件。在最大张力时,分别有 69.6%、73.9%和 68.2%的受试者在第 2、3 和 4 次访视时将其颈阔肌带评为“改善”或“显著改善”。

结论

IncobotulinumtoxinA 是一种有效且耐受性良好的颈阔肌带治疗方法,起效迅速,作用持续时间长。

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