EUCTR2021-004748-62-DE进行中（未招募）1 期
A Phase IV, Randomized, Interventional, Study to Assess Subject Treatment Session Perception and Investigator Treatment Experience of Alluzience and Vacuum-Dried Botulinum Neurotoxin Type A for Aesthetic Use
Q-Med AB, part of the Galderma Group0 个研究点目标入组 150 人开始时间: 2021年11月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- Female
入选标准
- •1.Female 18 to < 65 years of age.
- •2.Moderate to severe GL at maximum frown as assessed by the Investigator.
- •3.Female of non-childbearing potential (i.e., postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], or has undergone hysterectomy or bilateral oophorectomy). OR Female of childbearing potential with a negative urine pregnancy test at screening and baseline, and agrees to use a highly effective and approved contraceptive method for the duration of the study. A highly effective method of contraception is defined as:
- •Bilateral tubal ligation;
- •Combined (estrogen and progesterone containing) oral, intravaginal or transdermal contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit;
- •Hormonal or copper intra uterine device (IUD) inserted at least 28 days prior to Day 1;
- •Partner vasectomized for at least three months prior to screening visit;
- •Progestogen-only oral, injectable or implantable contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit; or
- •Strict abstinence (i.e., refraining from heterosexual intercourse for the entire duration of the subject's participation in the study).
- •4.Time and ability to complete the study and comply with instructions.
- •5.Understands the study requirements and signed the informed consent form (ICF).
- •6.Subjects who have planned to undergo aesthetic facial treatment with powder toxin at the study site.
- •7.Previous use of any approved botulinum toxin in facial areas.
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous use of any botulinum toxin in facial area within 6 months prior to study treatment.
- •2.Female who is pregnant, breast feeding, or intends to conceive a child during the study.
- •3.Known allergy or hypersensitivity to any component of the study product or any botulinum toxin serotype.
- •4.Any known contraindication such as subject with bleeding disorder or subject currently using anticoagulants.
- •5.Previous use of any hyaluronic acid soft tissue augmentation therapy in the treated area within 3 months before baseline.
- •6.Previous soft tissue augmentation with any permanent (non-biodegradable such as silicone, polyacrylamide, etc) or semi-permanent (i.e., calcium hydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) product; lifting threads, or autologous fat in the treatment area.
- •7.Subject has any prior or current psychiatric illness (e.g. Psychosis, depression, anxiety), alcohol or drug abuse, or is taking antidepressant, anxiolytic, or antipsychotic medication that, in the Investigator's opinion, could affect the subject's safety and/or participation in the study.
- •8.Other concurrent medical conditions, therapy, or other condition that, in the Investigator's opinion, would interfere with the evaluation of the study medication, safety or efficacy, and/or put the subject at risk if he/she participates in the study.
- •9.Participation in an investigational device or drug study within 30 days prior to study treatment or plans to enroll in any other investigational study during participation in this study.
- •10.Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.
研究者
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