NCT01745250已完成不适用
A Randomised, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Local tolerability
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of Emervel Lips and Juvederm Ultra smile
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects aged 18 to 65 years.
- •Subjects with the intention to undergo lip augmentation treatment.
- •Subjects treatment-naïve for lip augmentation treatment
- •Subjects with lip appearance judged by the treating investigator to be suitable for lip line treatment
- •Subjects with signed informed consent.
排除标准
- •Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs [NSAIDs]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.
- •Prior surgery or tattoo to the upper or lower lip or lip line.
- •Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry.
- •Previous tissue augmenting therapy in the lip area (including oral commissures, marionette and perioral lines) with HA or collagen filler, or laser treatment, within 12 months before study entry.
- •Permanent implant or treatment with non-HA or non-collagen filler in the area surrounding the lips (including nasolabial folds, oral commissures, marionette and perioral lines).
- •History of herpes labialis with an outbreak within 4 weeks of study entry or with 4 or more outbreaks in the 12 months before study entry.
- •Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
- •History of angioedema.
- •Previous hypersensitivity to HA.
- •Previous hypersensitivity to lidocaine or other amide-type anaesthetics
- •Cancerous or precancerous lesions in the area to be treated.
- •Immunosuppressive therapy, chemotherapy, treatment with biologics or systemic corticosteroids within 3 months before study treatment.
- •Pregnancy or breast feeding.
- •Participation in any other clinical study within 30 days before inclusion.
- •Other condition preventing the subject to entering the study in the investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the lower orbital rim, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
- •Study staff or close relative to study staff (e.g. parents, children, siblings or spouse).
研究组 & 干预措施
Emervel Lips
Experimental
Emervel Lips
干预措施: Emervel Lips (Device)
Juvederm Ultra Smile
Experimental
Juvederm Ultra Smile
干预措施: Juvederm Ultra Smile (Device)
结局指标
主要结局
Local tolerability
时间窗: 14 days
To assess local tolerability after treatment including erythema, bruising, itching, swelling, pain/ tenderness at 14 days. Number of subjects reporting the events will be analysed.
次要结局
- AE reporting(24 weeks)
- Global Aesthetic Improvement Scale (GAIS)(Week 2 to week 24)
- Subject's satisfaction(0-24 weeks)
- Lip Fullness Grading Scale (LFGS)(0-24 weeks)
研究者
研究点 (1)
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