NCT01176773已完成不适用
Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
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
- •18 years of age or older
- •Desire enhancement of his/her vermilion borders and/or vermilion mucosa Cupid's bow, philtral columns, perioral lines, and oral commissures may also be treated
- •Have a baseline score of Minimal of Mild, as assessed by the Investigator according to the 4-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked)
- •Have established a realistic Lip Fullness treatment goal that Investigator agrees is achievable
排除标准
- •Have undergone cosmetic facial, lip or perioral procedures [e.g., face-lift or other surgeries which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face or neck, or BOTOX® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. Note: Prior treatment with Hyaluronic Acid fillers and/or collage is allowed, provided the treatment was administered not less than 6 months prior to study entry
- •Have ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
- •Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to local anaesthesia agents, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study
- •Are pregnant, lactating, or planning to become pregnant at any time during the study
- •Have received investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
- •Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- •Have a history of or currently suffer from autoimmune disease
- •Have a history of treatment with interferon for chronic hepatitis C
- •Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken NSAIDs (e.g. aspirin, ibuprofen) or other substances known to increase coagulation time (e.g. herbal supplements with garlic or Gingko Biloba) within 10 days of undergoing study device injection. Note: Study device injection may be delayed as necessary to accommodate this 10-day wash out period
结局指标
主要结局
Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale
时间窗: 3 months
The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment
次要结局
- Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale(12 months)
- Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale(3 months)
- Number of Subjects Who Attain Their Lip Treatment Goal(1-12 months)
- Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale(12 months)
- Adverse Events(12 months)
研究者
研究点 (4)
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