A Prospective, Open-label Study to Evaluate Subject Satisfaction and Psychosocial Outcomes After Treatment of Jawline and Neck With BOTOX® Cosmetic and JUVÉDERM® Products
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Percentage of Participants With Response of Satisfied or Very Satisfied on Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction Follow-Up
研究概览
简要总结
The goal of this study is to evaluate overall participant satisfaction with the jawline and neck.
Participants will receive select Juvéderm products and onabotulinumtoxinA in the jaw area and neck per eligibility criteria.
The study will measure changes in psychological function, satisfaction with lower face and jawline and skin appearance. Participants will attend visits during the study at a clinical site. The effects of the treatment will be checked by medical assessments, vital signs, physical examinations, checking for side effects, and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or severe transverse neck lines based on investigator's live assessment
- •Moderate or severe loss of jawline definition based on investigator's live assessment.
- •Moderate or severe platysma prominence based on investigator's live assessment.
排除标准
- •History of or current medical condition that may put the subject at increased medical risk with exposure to BOTOX, or any other condition that might interfere with neuromuscular function.
- •History of or current symptoms of dysphagia.
- •History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
- •History of hypersensitivity or allergy to any botulinum toxin serotype, Streptococcal or gram-positive bacterial proteins, lidocaine, HA products, any other excipients or constituents of the study drug, device, and/or other products in the same class.
- •History of or tendency for keloid formation, hyperpigmentation, or hypertrophic scarring.
研究组 & 干预措施
JUVÉDERM Products Plus OnabotulinumtoxinA
Participants in the study will receive the products in the jaw area, chin, and neck.
干预措施: SKINVIVE (Device)
JUVÉDERM Products Plus OnabotulinumtoxinA
Participants in the study will receive the products in the jaw area, chin, and neck.
干预措施: VOLUX (Device)
JUVÉDERM Products Plus OnabotulinumtoxinA
Participants in the study will receive the products in the jaw area, chin, and neck.
干预措施: VOLUMA (Device)
JUVÉDERM Products Plus OnabotulinumtoxinA
Participants in the study will receive the products in the jaw area, chin, and neck.
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
Percentage of Participants With Response of Satisfied or Very Satisfied on Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction Follow-Up
时间窗: Day 104
The ANLFQ is a 5-point scale that assesses participant satisfaction. Response options range from Very satisfied to Very dissatisfied.
次要结局
- Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Psychological Function(Up to approximately 104 days)
- Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Satisfaction With Lower Face and Jawline(Up to approximately 104 days)
- Change From Baseline in Participant's Rasch-transformed Score of the SKIN-Q - Skin Looks(Up to approximately 104 days)
- Change From Baseline in Participant's Allergan Facial Confidence Scale (AFCS) - Confidence (Treatment Area) Total Score(Up to approximately 104 days)
- Percentage of Participants With Response of Improved or Much Improved on Investigator Global Aesthetic Improvement Scale (GAIS)(Up to approximately 104 days)
- Percentage of Participants With Response of Satisfied or Very Satisfied (or Agree or Definitely Agree) on Allergan Facial Satisfaction Scale (AFSS) - Natural Look and Feel(Up to approximately 104 days)