NCT03650218已完成不适用
A Prospective, Open Label, Dose-escalating, Multicenter Clinical Investigation to Evaluate the Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment
研究概览
简要总结
This is a prospective, open label, dose-escalating, multicenter clinical investigation to evaluate the safety and effectiveness of THIODERM STRONG in the correction of nasolabial folds.
The performance is assessed using the 5-point Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 12 compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Females of childbearing potential must have a negative urine pregnancy test at Screening/ Baseline visit and must agree to use an adequate method of contraception for the duration of the clinical investigation
- •Signed informed consent
- •Moderate to severe nasolabial folds (cohort 2)
- •Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evolution (cohort 2)
- •Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
排除标准
- •For females: pregnant and/ or lactating or planning to become pregnant during the investigation
- •History of allergies or hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-basede anesthetic
- •Tendency to keloid formation and/ or hypertrophic scars
- •Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
- •Recurrent herpes simplex in the treatment area
- •History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy
- •Diabetes mellitus or uncontrolled systemic diseases
- •History of bleeding disorder and/ or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post-injection
- •Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the investigator
- •Previous enrollment in this clinical investigation
- •Current participation in another clinical investigation, or treatment with any investigational drug/ medical device within 30 days prior to clinical investigation enrollment, or five half-lives of the investigational drug, whichever is longer
- •Any dependency of the subject to the investigator or investigation site, or subjects who are employees or relatives of the investigator
- •Subjects whose participation in clinical investigations is prohibited by the Austrian Medical Devices Act
- •Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance in the area of device application (cohort 2)
- •Implantation of facial dermal fillers in the treatment area in the preceding 12 months (cohort 2)
- •Skin of the nasolabial region affected by aesthetic treatments or planning to undergo such procedures during the clinical investigation (cohort 2)
- •Facial lipolysis, including submental fat treatments within last month prior to enrollment or planned during the clinical investigation (cohort 2)
- •Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation (cohort 2)
- •Planned dental/ oral surgery or modification within two weeks prior to injection and to a minimum of four weeks post injection (cohort 2)
结局指标
主要结局
Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment
时间窗: Week 12 compared to baseline
Scale from 0 (=none/ minimal) to 4 (= extreme)
Cohort 1: Frequency, severity, seriousness and causal relationship of AEs
时间窗: Up to 4 weeks
Cohort 1: Local tolerability assessment based on presence and intensity of erythema, swelling and skin hardening
时间窗: Up to 4 weeks
5-grade scale ranging from 0 (absent), over 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe)
次要结局
- Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)(Week 4, 12, 24, 36 and 52 compared to baseline)
- Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the investigator(Week 4, 12, 24, 36 and 52 compared to baseline)
- Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the subject(Week 4, 12, 24, 36 and 52 compared to baseline)
- Cohort 2: Subject satisfaction based on Face-Q questionnaire "Satisfaction with Outcome" Scale(Week 4, 12, 24, 36 and 52 compared to baseline)
- Cohort 2: Response rate based on blinded photographic reviewer's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)(Week 4, 12, 24, 36 and 52 compared to baseline)
- Cohort 2: Mean pain intensity score using the Numeric Pain Rating Scale (NPRS)(Immediately after administration and 15 minutes after treatment)
研究者
研究点 (4)
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