A Prospective, Open-label Study of the Safety and Efficacy of JUVÉDERM VOLUMA® to Enhance the Aesthetic Appearance of the Asian Nose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113
研究概览
简要总结
A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA® to enhance the aesthetic appearance of the Asian nose.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asian subjects aged 20 years of age or older with dissatisfaction of their aesthetic appearance due to structural features of their nose
- •Subjects who, in the opinion of the Investigator, can achieve a clinically meaningful aesthetic correction of their nose with VOLUMA® treatment
排除标准
- •-Subjects requiring filler treatment in or around the tip of the nose or between the eyebrows (glabellar region) to achieve a good aesthetic outcome
- •prior nasal surgery, including grafts, implants or filler injection to the nose area
- •Subjects with a history of sinusitis or rhinitis
- •Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product.
- •Subjects receiving botulinum toxin treatment for any indication within 3 months of the study or planning to receive botulinum toxin during the study
- •Subjects who have previously received aesthetic treatment in the forehead, glabellar, and/or nose area with any dermal filler
- •Subjects with a history of any significant adverse events caused by dermal fillers
- •Subjects with a history of allergic responses to lidocaine or fillers
- •Subjects who are pregnant or breastfeeding or wish to become pregnant during the study
- •Subjects of child-bearing age who are not prepared to practice an adequate form of contraception during the course of the study
- •Subjects with traumatic scars in the treatment area or a history of active inflammation, infection, cancerous lesion, or an unhealed wound in the treatment area
- •Subjects requiring dental or oral surgery, including dental implants, during the study period
- •Subjects with a history of bleeding disorders
- •Subjects who are smokers
- •Subjects using blood thinning products within 10 days of the screening visit
- •Subjects with a history of connective tissue disease (e.g., rheumatoid arthritis, lupus, scleroderma, etc) causing skin scarring
- •Subjects with a history of untreated epilepsy or other significant medical conditions
- •Subjects with a history of alcoholism or drug abuse of dependence
- •Subjects participating or likely to participate in another clinical trial within 30 days of screening or during the 1 year period of the study
- •Subjects with any other medical condition, which in the opinion of the Investigator, might compromise the subject's ability to tolerate the injection procedure or comply with requirements of the study
研究组 & 干预措施
JUVÉDERM VOLUMA®
Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
干预措施: Crosslinked hyaluronic acid gel (Device)
结局指标
主要结局
Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113
时间窗: Baseline, Day 113
The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 Grade Improvement from Baseline is reported.
Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113
时间窗: Baseline, Day 113
The independent central evaluating physician evaluated the improvement of the participant's nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.
次要结局
- Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)(Days 113, 239 and 421)
- Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others(Days 113, 239 and 421)
- Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician(Baseline, Days 239 and 421)
- Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient(Baseline, Days 239 and 421)
- Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)(Days 113, 239 and 421)