NCT03793348Unknown不适用
A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 11
- 主要终点
- Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale
研究概览
简要总结
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
详细描述
Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment.
Study results will be assessed with the following:
- Lemperle Scale
- Investigator GAIS 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
- 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
结局指标
主要结局
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale
时间窗: 90 day post treatment
A mean change of 1 point or greater reduction in cheek wrinkle severity at 90 days post treatment using the Lemperle Wrinkle Severity Scale, as assessed by (3) blinded Independent Reviewers Lemperle Scale: No wrinkles =0 Just perceptible wrinkles =1 Shallow wrinkles=2 Moderately deep wrinkles=3 Deep wrinkles, well-defined edges =4 Very deep wrinkles, redundant fold=5
次要结局
- Assess aesthetic improvement in wrinkles using OCT images (optional)(Baseline to Day 90 post treatment)
- Assess safety profile by reviewing completed 14 day subject diary for potential side effects.(For 14 days post treatment)
- Assess safety profile by recording of adverse events(Adverse events will be recorded immediately treatment, Day 1, Day 7, Day 30, Day 60 and Day 90 post treatment. Ad hoc assessment can occur upon subject report of AE.)
- Assess aesthetic improvement using Global Aesthetic Improvement Scale(90 day post treatment)
- Assess aesthetic improvement using Subject Satisfaction Scale(90 day post treatment)
- Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment.(Baseline to Day 90 post treatment)
研究者
研究点 (11)
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