NCT03166618终止不适用
A Multicenter, Single-Blind, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator Using the Allergan Temple Hollowing Scale (ATHS)
研究概览
简要总结
This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.
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
- •Has temple hollowing and is seeking restoration in the temple area.
排除标准
- •Has temple hollowing due to due to trauma, congenital malformations, or lipodystrophy
- •Has received permanent facial implants in the face or neck
- •Has undergone fat injections
- •Has tattoos, piercings, facial hair or scars that would interfere with visual assessment of the temple
- •Has undergone semipermanent dermal filler treatment in the temple or mid-face within the past 36 months
- •Has undergone dermal filler injections above the subnasale within the past 24 months
- •Has temporal arteritis or history of temporal arteritis
- •Has temporomandibular joint dysfunction
- •Has eye inflammation or infection
- •Has a history of detached retina, retinal vascular occlusion, narrow angle glaucoma, or neovascular eye disease
- •Has ever received a facelift, browlift, or facial reconstructive surgery
- •Has undergone mesotherapy or cosmetic treatment (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 or botulinum toxin injections within the past 6 months
- •Has experienced trauma to the temple within the past 6 months or has residual deficiencies, deformities, or scarring
- •Has a tendency to develop hypertrophic scarring
- •Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
- •Has porphyria or untreated epilepsy
- •Has active autoimmune disease
- •Has current cutaneous or mucosal inflammatory or infectious processes
- •Is on a lidocaine, anticoagulation therapy
研究组 & 干预措施
VOLUMA® XC Treatment
Experimental
Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.
干预措施: Juvéderm® VOLUMA XC (Device)
Control_No Treatment
No Intervention
No treatment is administered.
结局指标
主要结局
Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator Using the Allergan Temple Hollowing Scale (ATHS)
时间窗: Change from Baseline to Month 3
The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
次要结局
- Percentage of Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)(Month 3)
- Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS(Month 3)
研究者
研究点 (2)
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