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临床试验/IRCT20180515039672N3
IRCT20180515039672N3已完成4 期

The Phase IV study for assessment of the onset of action and Treatment EmergentAdverse Events of Dyston (Botulinum Toxin Type A- ImenVaccine Co.) in Glabellar Lines Improvement

Imen Vaccine Alborz0 个研究点目标入组 184 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
184

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 75 years(—)
性别
All

入选标准

  • 18 to 75 year old volunteer
  • Moderate to severe glabellar lines at maximum frown
  • Signed an informed consent form
  • Being agree with 14-day follow up

排除标准

  • Hypersensitivity to botulinum toxin or any other ingredients in the formulation
  • Taking the following medicines: aminoglycosides, penicillamine, quinine, chloroquine, hydroxychloroquine, calcium channel blockers, Anticoagulants (warfarin and aspirin)
  • Any aesthetic surgery (e.g. fillers injection, chemical peeling, laser) or any other materials causing remodeling of the skin or active changes in the glabellar area within the last 12 months
  • Previous history of any surgery in the facial muscles or scars in the glabellar area and the surrounding areas (including eyebrows)
  • The medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
  • History of facial nerve palsy
  • Marked facial asymmetry
  • History of the eyelid or eyebrow ptosis due to the facial muscle palsy
  • Any active infection or acute skin disease in the injection sites
  • Pregnant or lactating females

研究者

发起方
Imen Vaccine Alborz

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