临床试验/NCT05894109

NCT05894109尚未招募不适用

Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids

University of New Mexico0 个研究点目标入组 40 人开始时间: 2024年8月最近更新: 2024年5月10日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: University of New Mexico
入组人数: 40
主要终点: Duration of botulinum toxin on eyebrow excursion

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The current literature suggests that zinc supplementation may increase the duration of botulinum toxin; however, each study had their limitations. Further, no one has studied the effect of zinc supplementation for botulinum toxin treatment of the forehead. The purpose of this study is to evaluate the effect of zinc supplementation on frontalis muscle denervation by objectively assessing the degree of forehead rhytids and movement of the eyebrows.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Any patient older than 18 years old who desires botulinum toxin injection to decrease forehead rhytids

排除标准

•Allergy to any components of zinc citrate or botulinum toxin
•inflammation or infection at site of injection
•patients using anticholineresterase or other agents interfering with neuromuscular transmission
•patients with any medical condition that can affect frontalis function (Bell's palsy, Möbius syndrome, Hemifacial microsomia, CHARGE syndrome, stroke, etc)
•patients with any prior trauma that could have potentially injured the frontalis muscle
•patients dependent on intact facial movements and expressions for their livelihood (actors, singers, musicians, etc)

结局指标

主要结局

Duration of botulinum toxin on eyebrow excursion

时间窗: 1 year

Measurement of eyebrow excursion

Duration of botulinum toxin effect on forehead rhytids

时间窗: 1 year

Visual assessment of return of forehead rhytids

次要结局

Side effects of zinc administration(1 year)

研究者

发起方

University of New Mexico

申办方类型

Other

责任方

Principal Investigator

主要研究者

Jeffrey Wu

Associate Professor of Surgery

University of New Mexico

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