NCT02833077已完成不适用
A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 221
- 试验地点
- 28
- 主要终点
- Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score
研究概览
简要总结
This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chin retrusion
- •In good general health
排除标准
- •Permanent facial implants on the face and/or neck
- •Received fat injections below the nose
- •Tattoos, piercings, beard, mustache, and/or scars on the face below the nose
- •Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years
- •Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years
- •Received dermal filler injections in the lips or in the mouth area in the last 12 months
- •Undergone mesotherapy or cosmetic treatment (e.g., laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck in the last 6 months
- •Received botulinum toxin treatment below the nose in the last 6 months
结局指标
主要结局
Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score
时间窗: Baseline (up to 30 days prior to randomization) to Month 6
The evaluating investigator assessed the participant's chin retrusion based on 2-dimensional (2D) renderings of 3-dimensional (3D) images using the validated 5-point photonumeric ACRS where: 0= None (no chin retrusion) to 4=Extreme (extreme chin retrusion).
次要结局
- Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire(Baseline (up to 30 days prior to randomization) to Month 6)
- Percentage of Participants Improved or Much Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) for the Chin Area As Assessed by the Evaluating Investigator(Baseline (up to 30 days prior to randomization) to Month 6)
- Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants(Baseline (up to 30 days prior to randomization) to Month 6)
研究者
研究点 (28)
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