NCT03573271已完成不适用
A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of a Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment
研究概览
简要总结
Study evaluating the safety and efficacy of a micro-coring device for the treatment of moderate to severe cheek wrinkles.
详细描述
Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments.
Evaluation results will be based in the following:
- Wrinkle severity score assessed using the Lemperle Wrinkle Scale
- Subject Satisfaction Scale
- PI Global Aesthetic Improvement 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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 40-70 years of age
- •Fitzpatrick Skin Type I to IV as judged by the Investigator.
- •Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- •Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits
排除标准
- •Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
- •History of keloid formation or hypertrophic scarring
- •History of trauma or surgery to the treatment areas in the past 6 months
- •Scar present in the areas to be treated
- •Silicone injections in the areas to be treated
- •Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
- •Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
- •Active, chronic, or recurrent infection
- •History of compromised immune system or currently being treated with immunosuppressive agents
- •History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
- •Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
- •Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
- •History or presence of any clinically significant bleeding disorder
- •Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
- •Treatment with an investigational device or agent within 30 days before treatment or during the study period
- •Female and pregnant or plan on becoming pregnant during the study
研究组 & 干预措施
Micro-coring of facial/neck skin with MCD
Experimental
Micro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post treatment with MCD
干预措施: MCD (Device)
结局指标
主要结局
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment
时间窗: 90 day post treatment
Assess level of wrinkle improvement from the baseline to 90 day post treatment an Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale
次要结局
- Assess safety profile by recording of adverse events(90 days)
研究者
研究点 (9)
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