NCT06142643已完成不适用
Safety and Effectiveness Clinical Evaluation of Range of Injectable Medical Devices Viscol in Aesthetic Treatment
Kylane Laboratoires2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2023年12月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Performance at 1 Month Investigator Overall VISCOL Range
研究概览
简要总结
Evaluation of safety and performance of HA based injectable device for skin quality improvement
详细描述
The primary objective is to evaluate the effectiveness of the device used one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent investigator.
The secondary objectives of the study are to collect data on:
- the effectiveness four months (M4) after treatment.
- the effectiveness on the improvement of facial skin quality by objective measurements of skin biomechanical parameters using Cutometer® and skin hydration using Moisturemeter®.
- subject's satisfaction and subject's opinion on aesthetic improvement.
- the injector's satisfaction on the injection quality.
- the safety using clinical evaluation of the Injection Site Reactions (ISR).
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subject.
- •Sex: male or female.
- •Age: between 35 and 70 years.
- •Subject seeking an improvement for HA skin quality improvement product.
- •Subject with BMI <
- •Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study.
- •Subject having given his/her free, express, and informed consent.
- •Subject psychologically able to understand the information related to the study, and to give their written informed consent.
- •Subject registered with a social security scheme.
- •Women of childbearing potential should use a contraceptive method considered effective since at least 12 weeks and throughout the study
排除标准
- •In terms of population
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- •Subject in a social or sanitary establishment.
- •Subject suspected to be non-compliant according to the investigator's judgment.
- •Subject having received a total of 6.000 euros as compensations for their participation in clinical research in the last 12 months, including their participation in the present study.
- •Subject enrolled in another study or whose non-enrollment period is not over.
- •Subject with scar(s), mole(s), hair or any other lesion on the studied zones which might interfere with the evaluation (tattoo, permanent make-up…). In terms of associated pathology
- •Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety.
- •Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- •Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea, porphyria …) in the 6 months before screening visit.
- •Subject with a history of streptococcal disease or an active streptococcus infection.
- •Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
结局指标
主要结局
Performance at 1 Month Investigator Overall VISCOL Range
时间窗: 1 month
Primary endpoint was the percentage of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications, as assessed by the independent investigator, one month after treatment, using the GAIS (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 60%.
次要结局
- Performance at 4 Months Investigator Overall VISCOL Range(4 months)
- Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range(1 month & 4 months)
- Performance at 1 & 4 Months Subject Overall VISCOL Range(1 month, 4 months)
- Percentage of Indications With Response: GAIS Subject Overall VISCOL Range(1 month & 4 months)
- Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range(1 month & 4 months)
- Injector Satisfaction Questionnaire Viscol(D0 (Immediatly after injection))
- Subject Satisfaction Questionnaire Viscol(1 month, 4 months)
- Percentage of Participants Experiencing Adverse Events(6 months)
研究者
研究点 (2)
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