A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assess level of aesthetic improvement using ASAS scale 6 months post last treatment
研究概览
简要总结
A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.
详细描述
The study subject population will consist to up to 30 subjects who meet the inclusion/exclusion criteria. All subjects will be monitored for a period of 6 months post last treatment.
An study results will be assessed on the following:
- POSAS - Patient Observer Scar Assessment
- ASAS - Acne Scar Severity Scale
- Subject Satisfaction Scale
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Fitzpatrick scale I-VI.
- •Any type of scar except for keloid scars
- •Able to provide written informed consent, understand and willing to comply with study related procedures and follow-ups.
排除标准
- •Previous treatment of the scar tissue within last 6 months.
- •Silicone, fat, collagen or synthetic material in the treatment area.
- •History of keloid formation.
- •Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per day) for less than 3 months.
- •Active, chronic, or recurrent infection.
- •Compromised immune system (e.g. diabetes).
- •Hypersensitivity to analgesic agents.
- •Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
- •Pregnant or breastfeeding.
- •Any issue that, at the discretion of the investigator, would contra-indicate the subject's participation.
- •Any medication that may cause bleeding such as anticoagulants.
- •Allergy to lidocaine and/or epinephrine
研究组 & 干预措施
Micro-coring of scars with MCD
Micro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last treatment with MCD.
干预措施: MCD (Device)
结局指标
主要结局
Assess level of aesthetic improvement using ASAS scale 6 months post last treatment
时间窗: 6 months post last treatment
Assessing the improvement in the aesthetic appearance of the subject based on the Acne Scar scale comparing baseline to 6 months post last treatment. Grades range 0-4. Clear =0; Very Mild=1; Mild= 2; Moderate= 3; Severe= 4
Assess level of aesthetic improvement using POSAS scale 6 months post last treatment
时间窗: 6 months post last treatment
Assessing the improvement in the aesthetic appearance of the subject based on the POSAS scale comparing baseline to 6 months post last treatment. Parameters of vascularity, pigmentation, thickness, relief, and pliability, range from 1 to 10. normal skin =1; worst scar imaginable =10.
次要结局
- Assess safety profile by recording all adverse events reported during study(6 months post last treatment)