EUCTR2018-004696-12-IT进行中（未招募）1 期
Clinical, Instrumental and Histological evaluation of the combined use of Onabotulinumtoxin A and hyaluronic acid fillers in patients with facial paralysis - Onabotulinumtoxin A and hyaluronic acid fillers in the treatment of facial paralysis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Adult patients (18-65) with hemifacial paralysis from 3 to 6 on the House-Brackmann scale, never treated with HA and BTX injection will be included in the study.
- •-Signed informed consent.
- •-Women of childbearing potential will only be included in the study if uptaking the following highly effective birth control measures: Women of childbearing potential will only be included in the study if uptaking the following highly effective birth control measures: - Combined hormonal contraception associated with inhibition of ovulation (Oral, Transdermal, Intravaginal), - Progesteron-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable), - Intrauterine devices, - Intrauterine hormone-releasing system, - Bilateral tubal occlusion, - vasectomized partner, - Sexual abstinence
- •- Patients will be included after a negative highly sensitive pregnancy test (blood test)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Hypersensitivity to any component of the products used
- •-Diabetes, systemic diseases, coronary artery disease, acute-chronic hepatitis C, autoimmune diseases and / or other diseases involving poor general health, clotting problem. Peripheric neuro-muscolars disorders, amyotrophic lateral sclerosis (ALS).
- •-Pregnant or lactating
- •-Patients <18 years and >65 years old
研究者
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