NCT00850889已完成4 期
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Procedural Pain Score
研究概览
简要总结
Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Desires correction of moderate to severe nasolabial folds (NLFs)
- •Both NLFs have the same pre-treatment NLF severity score (either moderate or severe)
- •Females of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study
排除标准
- •Cosmetic facial procedures [e.g., facelift, resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative or non-ablative procedures), tissue augmentation with dermal fillers or fat injections, BOTOX Cosmetic injections, or mesotherapy] in the lower 2/3 of the face, including the neck, within 1 month prior to study entry or be planning to undergo any of these procedures at any time during the study
- •Initiating use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or during the study
- •Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment is within 5mL of the recommended annual maximum volume for HA dermal fillers
- •Previous injection of semi-permanent fillers or placement of facial implants anywhere in the head and neck or implantation of any of these products during the study
- •Allergy or sensitivity to lidocaine, hyaluronic acid products, or Streptococcal protein
- •Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region
- •Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections
研究组 & 干预措施
1
Active Comparator
Juvederm Ultra Injectable Gel with Lidocaine
干预措施: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine (Device)
2
Active Comparator
Restylane Injectable Gel
干预措施: A gel of hyaluronic acid (concentration of 20 mg/mL) (Device)
结局指标
主要结局
Procedural Pain Score
时间窗: 1 day
Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
次要结局
- Comparative Pain(1 day)
- Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity(Day 0, Day 14)
- Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity(Day 0, Day 14)
研究者
研究点 (1)
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