NCT02672644已完成4 期
A Single-Center, Non-Comparative Study to Evaluate Subject Recovery Following Correction of Bilateral Nasolabial Folds Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Subject-reported time of return to social engagement after initial treatment
研究概览
简要总结
Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep.
- to evaluate subject-reported return to social engagement, after the initial treatment (Baseline/Day 1 visit).
- to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30- subject/investigator reported
- to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.
- to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to post-treatment follow-up time points at day 14 and Day 30 - investigator reported
- to evaluate all adverse events during the course of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects, 35 to 60 years of age
- •Bilateral NLFs: severe (WSRS = 4/4) or moderate (WSRS = 3/3), as assessed by the treating investigator
- •Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
- •Childbearing potential is defined as not being surgically sterile (e.g., hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or those who are not post-menopausal (absence of menstruation for at least 1 year prior to Day 1).
- •If not surgically sterile or post-menopausal, the subject agrees to use acceptable forms of contraception. Acceptable methods of contraception are defined as follows:
- •use of oral/systemic contraceptives for at least 3 months prior to the start of the study; or
- •use of an intrauterine device; or
- •use of double barrier (e.g., condom or diaphragm and spermicidal foam/gel, condom and diaphragm); or
- •use of contraceptive implants or injectables for at least 28 days prior to the start of the study; or
- •partner with vasectomy at least 3 months prior to study start; or
- •strict abstinence.
- •Females of child bearing potential must have negative urine pregnancy test (UPT) at Day 1 and Day 14 if touch-up is to be performed.
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
- •Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area
- •Previous tissue augmenting therapy or contouring with permanent filler-type injectable product
- •Previous tissue augmenting therapy with non-permanent filler or fat-injection in the facial area to be treated, within twelve (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
- •Subject who presents with severe midface volume loss
- •Subject has a beard or facial hair that, in the investigator's opinion, would interfere with the study injections and/or study assessments
- •Woman who plans to become pregnant during the study
- •Woman who is pregnant or breast feeding
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
- •Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics
- •Known/previous allergy or hypersensitivity to gram-positive bacterial proteins
- •History of severe or multiple allergies manifested by anaphylaxis
- •History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation within two (2) weeks before treatment
- •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
- •Any medical condition or treatment that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion
- •Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees, or close relatives of employees at the Sponsor company
- •Participation in any clinical study within thirty (30) days before treatment
研究组 & 干预措施
Emervel Classic
Experimental
Subjects treated with Emervel Classic (moderate NLFs; WSRS = 3/3). Subjects receiving bilateral treatment of NLFs following approved product labeling.
干预措施: Emervel Classic (Device)
Emervel Deep
Experimental
Subjects treated with Emervel Deep (severe NLFs; WSRS = 4/4). Subjects receiving bilateral treatment of NLFs following approved product labeling.
干预措施: Emervel Deep (Device)
结局指标
主要结局
Subject-reported time of return to social engagement after initial treatment
时间窗: 30 days
Time of return to social engagement (in hours)
次要结局
- Change from baseline to post-treatment follow-up time points in subject reported GAIS(up to 30 days)
- Subject satisfaction with treatment outcome of the nasolabial folds(30 days)
- Change from baseline to post-treatment follow-up time points in treating investigator reported WSRS(30 days)
- Change from baseline to post-treatment follow-up time points in treating investigator reported GAIS(30 days)
- Incidence rate of subjects with adverse events (AEs)(30 days)
- Incidence rate of subjects with injection-related adverse events(30 days)
研究者
研究点 (1)
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