KCT0009443已完成Unknown
Clinical trial to evaluate the safety and efficacy for improvement trapezius hypertrophy of botulax® injection.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 20
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
- 20(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •1) A person between the ages of 20 and 60 who want contour correction of the gastrocnemius muscle
- •2) A person who can follow the clinical trial procedure well and abide by the visit schedule
- •3) Those who voluntarily signed the consent form
排除标准
- •1) Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motor neuropathy
- •2) Aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxants such as tubocurarine, dancrolen sodium, and baclofen, anticholinergics, and benzodiazepines) antibiotics, benzamide, tetracycline, lincomycin antibiotics, etc.)
- •3) Patients with a history of recent alcoholism or drug misuse
- •4) Patients with skin abnormalities such as infections, skin diseases, or scars at the injection site
- •5) If you have had other procedures that may affect gastrocnemius treatment within 6 months prior to baseline
- •6) Those who have received botulinum toxin preparations within 6 months before baseline
- •7) Patients with a history of facial nerve palsy or ptosis
- •8) Those taking aspirin, NSAIDs or anticoagulants
- •9) A woman who is pregnant, lactating, or of childbearing potential who does not agree to contraception by a medically accepted method for up to 8 weeks after drug administration
- •10) A person who has rapidly lost weight
- •11) Patients who are allergic or sensitive to investigational drugs or their ingredients
- •12) Those who are currently suffering from an acute disease
- •13) Those suffering from severe heart disease or respiratory disease
- •14) Patients who have participated in another clinical trial within 30 days before baseline or who have not passed the longer period of 5 times the half-life of the investigational drug of the clinical trial they participated in
- •15) Other patients who are not suitable for this test under the judgment of the investigator
研究者
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