NCT02573337已完成4 期
A Multi-center, Non-comparative Study to Evaluate the Perception of Facial Expressions Following Correction of Wrinkles and Folds in the Lower Face Using Emervel Classic Lidocaine and Emervel Deep Lidocaine
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Treatment impact on facial expressions
研究概览
简要总结
The purpose of this study is to evaluate the perception of facial expressions following correction of wrinkles and folds in the lower face using Emervel Classic Lidocaine and Emervel Deep Lidocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •NLFs assessed as moderate of severe using the WSRS
- •Intent to undergo optimal correction of both NLFs
- •Intent to undergo correction of at least one other wrinkle or fold in the lower face
排除标准
- •Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction
- •Subject who presents with severe midface volume loss
- •Subject who presents with facial hair, e.g. beard, moustache, in the treatment area
- •Woman who is pregnant or breast feeding or plans to become pregnant during the study
- •Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (inhaled corticoids are allowed) within three (3) months before study treatment
- •Previous surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area
- •Previous tissue augmenting therapy or contouring with permanent filler or fat-injection below the zygomatic arch
- •Previous tissue augmenting therapy, contouring or revitalisation treatment with non-HA filler, e.g. Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), below the zygomatic arch within 24 months before treatment
- •Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler below the zygomatic arch within 12 months before treatment
- •Previous tissue revitalisation treatment with neurotoxin below the zygomatic arch within six (6) months before treatment
- •Previous tissue revitalisation treatment with laser or light, mesotherapy, chemical peeling or dermabrasion below the zygomatic arch within six (6) months before treatment
- •Any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
结局指标
主要结局
Treatment impact on facial expressions
时间窗: 1 month after touch-up treatment
Perception of naturalness
次要结局
- Safety by assessment of local tolerability(2 weeks after first treatment)
- Aesthetic improvement of lower face(1 month after touch-up)
- Subject satisfaction with treatment outcome(1 month after touch-up)
- Nasolabial fold severity(Before treatment and 2 weeks after first treatment and 1 month after touch-up)
- Safety by assessment of Adverse Events(0-13 months)
- Treating investigator satisfaction with treatment outcome(1 month after touch-up)
研究者
研究点 (3)
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