Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Procedural Pain Score
研究概览
简要总结
Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.
详细描述
Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, 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
- •Be male or female, 18 years of age or older
- •Desire correction of moderate to severe nasolabial folds (NLFs)
- •Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score
排除标准
- •Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study.
- •Begin 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 are planning to begin use of such products during the study.
- •Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers.
- •Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study.
- •Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study.
- •Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the NLF area
研究组 & 干预措施
Juvederm with Lidocaine
Subjects receive Juvederm with Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in one nasolabial fold.
干预措施: JUVÉDERM™ Injectable Gel with Lidocaine (Device)
Juvederm
Subjects receive Juvederm without Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in the other nasolabial fold.
干预措施: JUVÉDERM™ Injectable Gel (Device)
结局指标
主要结局
Procedural Pain Score
时间窗: 1 day
Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
次要结局
- Nasolabial Fold (NLF) Severity(2 weeks)
- Comparative Pain(1 day)