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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- Time Needed to Prepare Alluzience and Powder BoNT A
研究概览
简要总结
This is a Phase IV, open-label, randomized, interventional, two-armed, multi-centre study to investigate subject treatment perception and Investigator treatment experience when using Alluzience or vacuum-dried botulinum neurotoxin type A (powder BoNT-A) for treatment of glabellar lines (GL).
详细描述
This is a Phase IV, open-label, randomized, interventional, two-armed, multi-centre study to investigate subject treatment perception and Investigator treatment experience when using Alluzience or vacuum-dried botulinum neurotoxin type A (powder BoNT-A) for treatment of glabellar lines (GL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female 18 to < 65 years of age.
- •Moderate to severe GL at maximum frown as assessed by the Investigator.
- •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.
- •Time and ability to complete the study and comply with instructions.
- •Understands the study requirements and signed the informed consent form (ICF).
- •Subjects who have planned to undergo aesthetic facial treatment with powder toxin at the study site.
- •Previous use of any approved botulinum toxin in facial areas.
排除标准
- •Previous use of any botulinum toxin in facial area within 6 months prior to study treatment.
- •Female who is pregnant, breast feeding, or intends to conceive a child during the study.
- •Known allergy or hypersensitivity to any component of the study product or any botulinum toxin serotype.
- •Any known contraindication such as subject with bleeding disorder or subject currently using anticoagulants.
- •Previous use of any hyaluronic acid soft tissue augmentation therapy in the treated area within 3 months before baseline.
- •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.
- •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.
- •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.
- •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.
- •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.
研究组 & 干预措施
Group 1 (Alluzience)
Single treatment at the baseline visit with Alluzience. Glabellar lines will be treated with 10 U/0.05 mL per injection point. In total 50 s.U in 0.25 mL for 5 injection points.
干预措施: Alluzience (Biological)
Group 2 (powder BoNT-A: BOTOX/Vistabel)
Single treatment at the baseline visit with powder BoNT-A (BOTOX/Vistabel). Glabellar lines will be treated with 4 U/0.1 mL per injection point. In total 20 U in 0.5 mL for 5 injection points.
干预措施: powder BoNT-A (BOTOX/Vistabel) (Biological)
结局指标
主要结局
Time Needed to Prepare Alluzience and Powder BoNT A
时间窗: Baseline (Day 0)
Time to prepare Alluzience and powder Bont A according to protocol was reported.
次要结局
- Investigator Treatment Session Questionnaire(Baseline (Day 0))
- Percentage of Participants Injected With Alluzience for Whom Investigator Did Not Face Technical Issue/Problems When Using a Ready-to-use Product as Compared to a Product to be Reconstituted(Baseline (Day 0))
- Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution(Baseline (Day 0))