NCT03712137已完成3 期
A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 206
- 试验地点
- 36
- 主要终点
- Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)
研究概览
简要总结
This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition
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
- 是
入选标准
- •Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the same on both sides, but must be Grade 2 or 3
- •Treating Investigator (TI) considers the subject's jaw amenable to an improvement of at least 1 grade on the scale for the jawline definition
- •Written Informed Consent (IC) has been obtained
排除标准
- •Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
- •Has ever undergone fat injections in the malar, chin or jawline area or is planning to undergo this procedure during the study
- •Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) below the subnasale within 36 months before enrollment or is planning to undergo such treatment during the study
- •Has received deoxycholic acid treatment in the submental region in the last 6 months
- •Has active autoimmune disease
- •Females who are pregnant, nursing, or planning a pregnancy during the course of the study
结局指标
主要结局
Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)
时间窗: Month 6
The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)
次要结局
- Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)(Month 6)
- Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)(Month 6)
- Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score(Baseline to Month 6)
研究者
研究点 (36)
Loading locations...
相似试验
终止
不适用
Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple HollowingTemple HollowingNCT03166618Allergan1
已完成
不适用
A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using CannulaAge-related Volume Deficit in the Mid-faceNCT03438266Allergan66
已完成
3 期
A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years OldTemple HollowingNCT04414397Allergan205
已完成
3 期
JUVÉDERM VOLUX® for Chin Retrusion in ChinaChin RetrusionNCT04559984Allergan150
已完成
3 期
A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital HollowingInfraorbital HollowingNCT03418545Allergan163