NCT04185909已完成不适用
A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of the Renuvion Dermal System for Dermal Resurfacing
适应症
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
- 8
- 主要终点
- Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS)
研究概览
简要总结
This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides.
详细描述
This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides. All study subjects will be treated with the Renuvion Dermal System.
The study population will consist of males and females, 30 years of age or older, requesting a procedure for the purpose of improving facial appearance by reducing facial wrinkles and rhytides. Those subjects who meet eligibility criteria and agree to provide written informed consent will be invited to participate.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 4 on the FWS.
- •Subject with a Fitzpatrick Skin Scale score ≤III.
- •Subjects who are willing and able to take protocol allowed medications prescribed at investigator discretion which may include Keflex or Z-pack as an antibiotic, Acyclovir or Valtrex as an antiviral, Diflucan as an antifungal, Ativan or Valium for anxiety during treatment, Norco or Ultram for pain control during or post-procedure, Gabapentin, Tylenol with Codeine or NSAIDS for post-procedure pain control, and/or Antihistamines for itching during healing.
- •Subjects who are willing to have polycarbonate eye shields placed for study treatment.
- •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, post-care instructions, and returning for follow-up visits.
- •Subject is willing to maintain baseline skin care regimen during study participation with the exception when protocol specified ointments, moisturizers, and cleansers are required during healing stage (through approximately the 30-day follow-up). Sunblock is required throughout the study starting on approximately day
- •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 ≥IV.
- •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 30 days prior to screening or plans to use during study participation, Accutane, Retinol, or any medication that can cause dermal hypersensitivity.
- •Subject has used, within 10 days prior to study treatment, aspirin or NSAIDs.
- •Subject has a history of autoimmune disease (excluding Hashimoto's thyroiditis).
- •Subject with a known bleeding disorder or who is on blood thinning medication that may be at risk for bleeding.
- •Subject has a known adverse reaction to lidocaine and/or epinephrine.
- •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 effectiveness 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 within 12 months prior to the screening visit.
- •Subject has received IPL, microneedling, or chemical peels within 3 months prior to the screening visit.
- •Subject has received microneedling with RF or any facial treatment with an energy-based device within 6 months prior to the screening visit.
- •Subject has received facial injections with BOTOX® or other toxins within 6 months prior to the screening visit.
- •Subject has received hyaluronic acid or calcium hydroxylapatite fillers within 4 months prior to the screening visit.
- •Subject who is a family member or employee of the investigator or sponsor.
- •Participation in any other investigational study within 30 days prior to consent.
- •Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
结局指标
主要结局
Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS)
时间窗: 90-day
The FWS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower the value, the better the outcome. Three Independent Photographic Reviewers were blinded to the study subject's visit (Day 90 follow-up visit) and performed photographic assessments of each subject's wrinkle depth in the treated zones.
次要结局
未报告次要终点
研究者
研究点 (8)
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