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临床试验/NCT05034965
NCT05034965Unknown早期 1 期

Dynamic Changes in Some Facial Muscles After Superficial Versus Deep Hyaluronic Acid Injection: An Electromyographic Study

Alexandria University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
30
试验地点
1
主要终点
electrophysiological changes in some facial muscles

研究概览

简要总结

assess electrophysiological changes in some facial muscle dynamics following hyaluronic acid filler injection in superficial versus deep level of injection.

详细描述

Participants will be subjected to injection of cross-linked hyaluronic acid fillers on both sides of the face in 3 different regions: temples, cheeks and chins.

Each female will undergo:

  1. Before injection:

  2. Aesthetic facial clinical analysis.

  3. Baseline quantitative surface electromyography.

  4. Baseline digital photography.

  5. Injection:

Each female will receive the injection in the particular facial region at superficial level to the muscle (subcutaneous) on one side and the same amount at deep level to the muscle (supraperiosteal) on the other side. 3. One week after injection:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 20-60 years.
  • Sex: females.
  • Areas eligible for injection: temples, cheeks and chin.

排除标准

  • Active infection near the site of injection.
  • Pregnant or lactating women.
  • Patients suffering from any neuromuscular disorders.
  • Known allergy/hypersensitivity to hyaluronic acid fillers.
  • History of botulinum toxin injection in the last 4 months.
  • History of injection of fillers in the last 2 years.
  • Patients receiving any muscle relaxants.
  • Coagulation disorder or anticoagulants therapy.

研究组 & 干预措施

deep injection of hyaluronic acid fillers

Active Comparator

Each female will receive filler injection deep to the muscle (supraperiosteal) on one side of the face.

干预措施: hyaluronic acid filler injection (Drug)

superficial injection of hyaluronic acid fillers

Active Comparator

Each female will receive filler injection at superficial level to the muscle (subcutaneous) on the contralateral side(same dose and same site).

干预措施: hyaluronic acid filler injection (Drug)

结局指标

主要结局

electrophysiological changes in some facial muscles

时间窗: one week

baseline and follow up quantitative surface electromyography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

marwa eldeeb

lecturer of dermatology

Alexandria University

研究点 (1)

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