A Randomised, Subject-blinded Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride 0.3%
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.
研究概览
简要总结
The objectives of this study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained. The study products will be administered in the cheek.
详细描述
The Restylane SubQ gel is intended to be used for facial tissue augmentation. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this split-face designed study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained with the dermal filler using the global esthetic improvement scale (GEIS).
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 (Participant)
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.
- •Intent to undergo contouring of both cheeks with 1.5 to 2 ml Restylane SubQ per cheek.
- •Sufficient symmetry of the face in order to ensure similar volume to be injected, similar injection technique and time for injection.
- •Signed informed consent.
排除标准
- •Surgery in the midface including aesthetic facial surgical therapy, sinus surgery or dental root surgery within the past 12 months.
- •Chronic infection in head and neck region.
- •Ongoing infections in mouth.
- •Tendency for edema, puffiness or swelling over the zygomatic prominence.
- •Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
- •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 non-permanent filler, laser treatment, or chemical peeling during the last 6 months.
- •Permanent implant placed in the area to be treated.
- •Reduced sensibility in the facial region e.g. due to trauma, facial pareses, previous tissue augmenting therapy, aesthetic facial surgical therapy, laser treatment, or peeling.
- •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 upper orbital rim, subjects anticipated to be unreliable or incapable of understanding the VAS assessment, insufficient tissue support or cover of the treatment area.
结局指标
主要结局
Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.
时间窗: When injection of both cheeks were completed
When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).
次要结局
- Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)(2 weeks)
- Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.(15 and 120 minutes)
- Number of Subjects Reporting Adverse Event(Up to 12 months)
- Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks(2 weeks)
- Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment.(14 days)