A Prospective, Multi-center, Randomized Pilot Study for the Safety and Efficacy of a GEN II Micro-coring Device for the Treatment of Wrinkles and Skin Laxity in the Pre-auricular Area and Mid to Lower Face
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 9
- 主要终点
- improvement in wrinkle appearance
研究概览
简要总结
A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal initiating a skin repair process through formation of new collagen and elastin fibers (skin rejuvenation).
详细描述
This is a prospective, multi-center, randomized, single blind, bilateral paired study evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device for removal of excess skin using 2 needle gauges (22G, 24G,) at densities (percent of skin removed per 1cm2) of 2.5-10% in subjects with mid- and lower- face skin laxity manifested by moderate-to-severe mid and lower cheek wrinkles, deepening of the nasolabial folds at rest; prominence of marionette lines at rest; downturn of the oral commissures at rest, sagging of the skin at the jawline at rest. Subjects are blinded to needle gauge and density.
There will be two cohorts of subjects: one group of subjects will receive a single treatment and the second - multiple treatments. All subjects will be followed for 180 days with several intermediate visits at 3, 7, 30, 60, and 90-days.
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
盲法说明
subject is blinded to the needle gauge and density of treatment
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator
- •One or more of the following conditions assessed by Investigator using provided Severity Scales:
- •Nasolabial fold severity at rest ≥2 and ≤4;
- •Marionette line prominence at rest ≥2 and ≤4;
- •Oral commissure drooping at rest ≥2 and ≤4;
- •Jawline sagging at rest ≥2 and ≤4 .
- •Moderate-to-Severe wrinkles at rest at least in one of the following areas - the upper lip, chin and cheeks.
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 or synthetic material injections in the areas to be treated
- •Injection of FDA-approved dermal fillers in the past two years
- •Injection of fat in the past year
- •History of treatment with dermabrasion, ablative laser, or radiofrequency in the past year
- •History of treatment with non-ablative laser in the past 6 months
- •History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
- •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
- •Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
- •History of drug and/or alcohol abuse
- •Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
- •Treatment with an investigational device or agent within 30 days before treatment or during the study period
研究组 & 干预措施
micro-excisional skin removal
Facial and neck wrinkles will be treated with micro-excisional skin removal
干预措施: micro-excisional skin removal with coring needle (Device)
结局指标
主要结局
improvement in wrinkle appearance
时间窗: 60 and 90 days
One grade or better improvement in score on Wrinkle Severity Scale
次要结局
- improvement in skin laxity(up to 180 days)