A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apyx Medical
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score
研究概览
简要总结
This study evaluates the safety and effectiveness of J-Plasma in the reduction of facial wrinkles and rhytides. It is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides and will be conducted at up to 5 investigational centers in the United States. Each study subject will receive one procedure with J-Plasma at enrollment. Follow-up will occur immediately following the procedure, at 10 days, 1, 3, and 6 months after enrollment.
详细描述
The study objective is to demonstrate the safety and efficacy of the J-Plasma system for use in dermal skin resurfacing.
This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides at up to 5 investigational centers in the United States.
Study subjects that meet study eligibility criteria and have provided informed consent will be enrolled in the study. During the procedure, the investigators will use J-Plasma on applicable facial zones to reduce wrinkles and rhytides.
Study subjects will be followed immediately following the procedure, at 10 days, 1, 3, and 6 months post-procedure for study assessments.
Study enrollment is expected to occur over 3-6 months. Imaging and study assessments will continue through 6 months post-procedure. Total study duration is expected to be approximately 9-12 months.
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
This is a single-arm study in which investigators are not blinded. However, blinded Independent Photographic Reviewers (IPR) will be utilized to review all images (baseline and all follow-up time points) and assign FWS scores.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects ≥30 years of age.
- •Subject is seeking improvement of facial appearance by reducing facial wrinkles and rhytides.
- •Subject with a facial wrinkle score rating of at least 2 on the FWS as determined by the investigator.
- •Subject with a Fitzpatrick Skin Scale score ≤III.
- •Subject is willing and able to provide written informed consent.
- •Subject is willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
- •Subject is willing to release rights to study Sponsor for the use of the photos, including in potential publication.
- •Subject is willing to abstain from other facial cosmetic procedures through the 6 month follow-up visit; examples include, but are not limited to, laser or chemical re-surfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial surgery, etc.
排除标准
- •Subject with a Fitzpatrick Skin Scale score >III.
- •Subject is pregnant or lactating.
- •Active HSV-1 or diabetes mellitus.
- •Active cut, wound, or infection on the skin of the face.
- •Subject has used, within the past 30 days, Accutane or any medication that can cause dermal hypersensitivity.
- •Subject has a history of autoimmune disease.
- •Subject with a bleeding disorder or who is on blood thinning medication that may be at risk for bleeding.
- •Subject has a known adverse reaction to anesthetics.
- •Subjects with active skin disease of the facial area or known connective tissue disease.
- •Subjects with known susceptibility to keloid formation or hypertrophic scarring.
- •Subjects with present cancerous or pre-cancerous lesions in the area to be treated.
- •Subject who, for any reason, suspects that they will not be able to complete the prescribed follow-up assessment(s);
- •Subject has had concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety and efficacy of the study treatment method.
- •Subject is not willing to release rights to study Sponsor for the use of the photos, including in potential publication.
- •Subject is enrolled in another investigational (drug or device) clinical trial that can interfere with this study's assessments.
- •Subject has undergone a facelift procedure or received facial injections within the past year.
结局指标
主要结局
Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score
时间窗: Baseline to 3 months
The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement.
Adverse Event Rate and Duration
时间窗: Up to 3 months
Adverse event rates, categorized by duration
次要结局
- Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an "Improved" Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit.(Baseline to 3 months)
- Evaluation of Pain and Discomfort(Baseline to 3 months)