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Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines? (toxin)

2026年11月2日 更新者:Alain Michon、Project Skin MD

Effect of Sequential trenibotulinumtoxinE on the Duration of onabotulinumtoxinA Effect in Lateral Canthal Lines: An Exploratory, Randomized, Placebo-Controlled, Split-Face Pilot Study

This pilot study will look at whether trenibotulinumtoxinE can shorten or reverse the effect of onabotulinumtoxinA in people being treated for lateral canthal lines (also called crow's feet). OnabotulinumtoxinA is a commonly used treatment that relaxes the muscles around the eyes and smooths these lines, and its effect usually lasts about three to four months. Some people may want the effect to wear off sooner. This study will test whether giving trenibotulinumtoxinE after onabotulinumtoxinA changes how long the effect lasts.

Participants will receive onabotulinumtoxinA on both sides of the face. Using a split-face design, one side of each person's face will then be randomly assigned to receive trenibotulinumtoxinE and the other side will receive a placebo. This lets each person act as their own comparison. [Number] adults will take part, and they will be followed for [length of follow-up] to see how long the effect on each side of the face lasts. The main measure is [primary outcome, e.g., time until lateral canthal line severity returns to baseline on each side]. Safety and side effects will also be recorded.

研究概览

研究类型

介入性

注册 (估计的)

4

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Inclusion criteria Adults aged 18 to 65 years. Moderate to severe lateral canthal lines (crow's feet) at maximum smile on both sides, bilaterally symmetrical, as rated by the investigator on the Facial Wrinkle Scale (grade 2 or 3).

Good general health, based on medical history and physical examination. Willing to receive onabotulinumtoxinA in both lateral canthal areas, accept random assignment of trenibotulinumtoxinE or saline to each side, and attend all study visits and photography.

Women of childbearing potential agree to use effective contraception during the study.

Written informed consent.

Exclusion Criteria:

  • Any botulinum toxin (any serotype, any site) in the previous 6 months. Known hypersensitivity to any botulinum toxin or to the excipients, or a history of resistance or immunization to botulinum toxin.

Neuromuscular disease (myasthenia gravis, Lambert-Eaton syndrome, ALS, motor neuropathy) or any condition affecting neuromuscular function.

Use of medications that potentiate botulinum toxin (such as aminoglycosides, curare-like agents) in the past 4 weeks.

Facial nerve palsy, eyelid or brow ptosis, marked facial asymmetry, or excessive dermatochalasis.

Deep dermal scarring, or inability to substantially lessen the lines by spreading the skin apart.

Previous surgery of the periorbital area (blepharoplasty, brow lift), or fillers, laser resurfacing, deep peels, or other cosmetic procedures in the periorbital area in the past 6 to 12 months.

Active infection or skin disease at the injection sites. Pregnancy, breastfeeding, or planned pregnancy during the study. Anticoagulant therapy or a bleeding disorder (increased risk of bruising). Participation in another clinical trial within 30 days. Any condition that, in the investigator's opinion, could put the participant at risk or confound the results.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:TrenibotulinumtoxinE Side

OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. One side of the face, chosen at random, then receives trenibotulinumtoxinE. The other side receives placebo (see Placebo Side arm).

OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. One side of the face, chosen at random, then receives trenibotulinumtoxinE. The other side receives placebo (see Placebo Side arm).

安慰剂比较:Placebo Side

OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. The side of the face not assigned to trenibotulinumtoxinE receives placebo.

OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. The side of the face not assigned to trenibotulinumtoxinE receives placebo.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Duration of OnabotulinumtoxinA Effect on Lateral Canthal Lines
大体时间:From onabotulinumtoxinA injection through day 120.

Time in days from onabotulinumtoxinA injection until lateral canthal line severity at maximum smile returns to baseline (pre-treatment) severity, measured separately for each side of the face using [rating scale, e.g., the validated Facial Wrinkle Scale] by a blinded assessor. The duration will be compared between the side treated with trenibotulinumtoxinE and the side treated with placebo.

From onabotulinumtoxinA injection through day 120.

次要结果测量

结果测量
措施说明
大体时间
Change in Lateral Canthal Line Severity at Maximum Smile
大体时间:From day 0 to day 120.

Change from baseline in severity on each side of the face, rated by a blinded assessor using Allergan Facial Wrinkle Scale. Compared between the trenibotulinumtoxinE side and the placebo side.

From day 0 to day 120.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared. This pilot study includes only 4 participants, and the data include standardized facial photographs and detailed split-face assessments that cannot be adequately de-identified without a risk of re-identifying participants. Participants have not consented to public data sharing. Aggregate, de-identified results (individual-level descriptions without identifying information) will be reported in publications and in the ClinicalTrials.gov results section if applicable.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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