Quality of Life After Cosmetic Treatments: a Prospective, Controlled Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,080
- 主要终点
- FACE-Q Psychological Wellbeing
研究概览
简要总结
Prospective cohort study, investigating the pre-post treatment effect of cosmetic injectable and surgical treatments on quality of life (primary outcome measure: FACE-Q Psychological, secondary outcome measure: FACE-Q Social), compared with a non-treated control group. Propensity score analysis is used to reduce confounding by indication.
详细描述
Methods
Study design and setting
This is a prospective controlled nationwide multicenter cohort study with repeated measurements in adults receiving cosmetic treatment at a chain of cosmetic clinics in the Netherlands and untreated controls. The study is designed to evaluate changes in quality of life following cosmetic treatment over a follow-up period (botulinum toxin: 2 months; hyaluronic acid filler: 3 months; surgery: 1 year). Untreated controls are sisters of treated female participants and were recruited to provide a comparison group with partial genetic and socio-economic similarity. To reduce seasonal and broader temporal influences on quality of life, controls complete the baseline questionnaire within the same calendar start month and year as the corresponding treated participant.
The study includes a broad overall treated cohort and prespecified treatment strata. The primary comparison is treated participants versus untreated controls. Secondary comparisons are performed within treatment classes, and tertiary comparisons within individual treatment groups.
Participants
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
- 是
入选标准
- •Clients who have booked a cosmetic treatment (injectables or surgery) in one of the contributing clinics in the Netherlands
排除标准
- •Regular contra-indications as per clinic protocol / physician judgment
结局指标
主要结局
FACE-Q Psychological Wellbeing
时间窗: Botulinum neurtoxin type A: From baseline to 2-months follow-up Hyaluronic acid dermal fillers: From baseline to 3-months follow-up Surgery: From baseline to 12-months follow-up
Change in score from baseline to follow-up
次要结局
- FACE-Q Social function(Botulinum neurtoxin type A: From baseline to 2-months follow-up Hyaluronic acid dermal fillers: From baseline to 3-months follow-up Surgery: From baseline to 12-months follow-up)
研究者
Prof. dr. J. de Lange, MD DMD
Prof. dr. J. de Lange, MD DMD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)