Safety, Longevity and Patient Satisfaction Comparison of Four Hyaluronic Acid Soft Tissue Fillers in Lip Augmentation: Study Protocol for a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 8
- 主要终点
- Longevity of absolute lip volume augmentation
研究概览
简要总结
There is need for evidence-based and reproducible data comparing the safety, longevity and patient satisfaction propensity of the various HA soft tissue filler products. Among cosmetic HA soft tissue filler procedures, especially the lip augmentation has become common. Therefore, the aim of this study is to determine whether a statistically significant difference can be detected in the safety, longevity and/or patient satisfaction related to four HA soft tissue filler products widely used for cosmetic lip augmentation. Specifically, the aim of this study is to determine whether superiority of one or more product(s) over the others can be detected.
详细描述
Rationale: Currently, hyaluronic acid (HA) soft tissue fillers are widely employed in cosmetic medical practice for facial contouring and rejuvenation. Among these procedures, especially the lip augmentation has become common. To this end various products have become commercially available, however to date no robust evidence is available to support the safety, longevity or patient satisfaction propensity superiority of one product over the others.
Objective: To assess whether superiority in safety, longevity and patient satisfaction propensity can be shown of one of four most frequently used FDA-approved and/or CE marked HA fillers worldwide, used to augment the lip, over the others.
Study design: Multi-center, randomized, controlled, four group, parallel, triple-blind clinical trial of 160 adult participants.
Study population: Consecutive healthy individuals with no history of previous lip treatment and a self-reported wish for lip augmentation, who present at one of the private cosmetic medicine clinics in the Netherlands, will be recruited.
Intervention (if applicable): After giving informed consent, participants will be randomized to receive a protocoled lip augmentation procedure by the injection of either 1 mL of brand A, B, C or D.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant, Care Provider, Investigator, Outcome Assessor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or over.
- •Female sex.
- •No history of previous lip augmentation treatment.
- •Oral and written informed consent to participate in the study.
- •Desire for cosmetic lip augmentation to improve one's physical or mental well-being.
- •Actively treatment seeking (patient actively chooses to make an appointment at a Faceland private cosmetic clinic without invitation).
- •Small to moderately full lip volume (Merz Lip Scale score 0 - 2 out of 4).
排除标准
- •Active peri-oral infection in vicinity of injection site
- •Tumour in vicinity of injection site
- •Active tuberculosis
- •Pregnant or breast-feeding
- •History of severe hypersensitivity to filler components (sodium hyaluronate preparations or local anesthetics of the -amide type, gram-positive proteins, wasps/bees or the hyaluronidase enzyme)
- •Active collagenosis (e.g., active systemic lupus)
- •Graft vs. host disease
- •Active Hashimoto's disease
- •Use of thrombolytics or anticoagulants with high bleeding risk
- •General infection
- •Porphyria
- •Untreated epilepsy
- •Keloid tendency
- •Cardiac arrythmia
- •Severe liver or kidney disease
- •Fulfilling the DSM-5 diagnostic criteria for Body Dyspmorphic Disorder
- •Concurrent laser- peeling- or dermabrasia treatment
结局指标
主要结局
Longevity of absolute lip volume augmentation
时间窗: from baseline to 3-months follow-up
The primary outcome will be the longevity of the absolute lip volume augmentation, as measured by the modified Lemperle Lip Index (vertical height in mm).
次要结局
- Quality of Life (Social)(baseline to 3-months follow-up)
- Patient satisfaction (lip appraisal)(from baseline to 3-months follow-up)
- Quality of Life (Psychological)(baseline to 3-months follow-up)
- Product safety (serious adverse events)(baseline, 2-weeks and 3-months follow-up)
研究者
Prof. dr. J. de Lange
Prof. dr. J. de Lange, Head of OMFS Surgery, Principal Investigator, Clinical Professor, at AUMC - location AMC
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)