A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Primary endpoint
研究概览
简要总结
A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips
详细描述
This post-market, prospective, non-interventional, open label study is designed to demonstrate the performance and safety of RefillHA Lips in routine clinical practice for remodelling and correction of mild defects of the lips.
Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with RefillHA Lips will be offered to participate in the study. The investigators will enroll in any subject who receives at least one injection with RefillHA Lips and have provided informed consent. They will follow their routine practice regarding injection technique, volume, and subject follow-up. Treatments will be performed for a single indication or for multiple indications where correction is requested, subject to the advice of the practitioner and in accordance with the product intended use and conditions. Any indication can be retreated at any time throughout the duration of the study, as per routine practice. The area to be treated and injection characteristics - volume, depth, and technique - are all left to the discretion of the practitioner.
The study protocol includes an initial visit (baseline) and follow-up visits at months 1, 3, 6, 9, and 12 from baseline, in accordance with the non-interventional study design. Additional visits are allowed at any time throughout the follow-up period at the patient's request or when deemed necessary. At each visit, in addition to the safety assessment, performance will be evaluated through an area-specific assessment of the lips.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women of any race, 18 years of age or older.
- •Able to read, understand and sign informed consent.
排除标准
- •Subjects with known contraindications to the treatment with RefillHA Lips, as per the device IFU.
- •Patients with multiple and/or severe allergies or history of anaphylaxis.
- •Pregnant or lactating women (contraindications as per IFU).
- •Having received prior dermal filler injections in the six months preceding the study.
- •Previously treated with semi-permanent or permanent filler in the intended injection area.
- •Presenting with a cutaneous disorder, inflammation or infection near to the treatment area.
- •Known hypersensitivity to lidocaine and/or lidocaine HCl or hyaluronic acid.
- •Metabolic or endocrine uncontrolled disease, anaphylaxis, severe allergies or uncontrolled immune disorder.
- •Undergoing or planning to undergo peeling treatment or laser-/ultrasound-based treatment within 3 weeks before or after injection.
- •Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs such as aspirin, ibuprofen), or other substances known to prolong time of coagulation from a week before treatment. A wash-out period of a week is allowed.
- •Subject who has a condition or is in a situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study or with protocol evaluation parameters.
研究组 & 干预措施
Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with RefillHA Lips
结局指标
主要结局
Primary endpoint
时间窗: Up to 56 weeks after treatment
The proportion of subjects with Global Aesthetic Improvement Scale (GAIS) scores 1-3 (responders) in the lips at months 6, 9 and 12 after initial injection, as assessed by the investigator (iGAIS). \[Scores 1-3 correspond to 'Very much improved', 'Much improved', and 'Improved' (see Section 12.1).\]
次要结局
未报告次要终点