An Open, Multi-center Study Evaluating Efficacy, Safety and Injection Technique of Restylane Lip Products for Lip Enhancement and Lip Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the injection technique.
详细描述
Restylane Lip Volume is intended to be used for lip enhancement and Restylane Lip Refresh is intended to restore hydrobalance and improve skin structure of the lips (referred to as lip rejuvenation in this protocol), respectively. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this open, multicenter study are to evaluate efficacy and safety of the products for the studied indications and to collect information on injection techniques used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 60 years of age.
- •Intent to undergo lip augmentation or rejuvenation of both the upper and lower lip.
- •Signed informed consent.
排除标准
- •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.
- •A history of herpes labialis and an outbreak within four weeks of study entry or with four or more outbreaks in the 12 months prior to study entry.
- •Presence of facial hair that may interfere with efficacy evaluations.
- •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 hyaluronic acid or local anesthetics.
- •Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders.
- •Cancerous or pre-cancerous lesions in the area to be treated.
- •Previous tissue augmenting therapy in the area to be treated with hyaluronic acid (HA) or collagen filler, or laser treatment, during the last 12 months.
- •Permanent implant placed in the area to be treated or treatment with non-HA or non-collagen filler in the area to be treated.
- •Pregnancy or breast feeding.
- •Participation in any other clinical study within 30 days prior to 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).
结局指标
主要结局
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment
时间窗: At week 8 - change of lips from baseline
To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.
次要结局
- GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment(week 36 - change from baseline)
- GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment(week 36 - change from baseline)
- Subject Satisfaction Questionnaire(Week 8)
- Subject Diary for 14 Days After Initial Treatment(2 weeks after initial treatment)
- GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment(week 36 - change from baseline)
- MLFS (Medicis Lip Fullness Scale) at Week 8(week 8 - change from baseline)