NCT06111482招募中不适用
Clinical Study to Evaluate Different Energy-based Devices for Aesthetic Treatments.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Maximum pain reported during treatment.
研究概览
简要总结
The goal of the energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions.
详细描述
Up to 50 subjects will be enrolled at 1 study center. Subjects will be enrolled into 4 groups: Group A, Group B, Group C, or Group D. Subjects may enroll in more than one group, however the last treatment in the previous group would be at least 30 days before the subject is enroll in the next group if treatment area is the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A healthy male or female 22 years of age or older.
- •Willing to undergo at least 1 treatment with the study device(s).
- •Understands and accepts obligation not to receive any other procedures in the treatment area through the length of the study.
- •Understands and accepts the obligation and is logistically able to be present for all visits.
- •Is willing to comply with all requirements of the study and sign the informed consent document
排除标准
- •Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- •Takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
- •Is using systemic steroids (e.g., prednisone, dexamethasone) prior to or during the course of treatment.
- •Is receiving or has received gold therapy.
- •Is taking medications that alter the wound-healing response or has a history of healing problems.
- •Has an active localized or systemic infection, or an open wound in area being treated.
- •Has a significant systemic illness, such as lupus, or an illness localized in area being treated.
- •Has a seizure disorders triggered by light.
- •Has a history of skin photosensitivity disorders.
- •Has a history of hypertrophic scars or keloid formation.
- •Has a history of radiation therapy in area to be treated.
- •Received fillers or neurotoxin injections in the treatment area within the past 2 weeks.
- •Has had a chemical or mechanical epilation within the last six weeks.
- •Currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months to entering this study.
- •Has any condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
- •Radiofrequency Device Only:
- •Has a Pacemaker
- •Has any embedded electronic devices that give or receive a signal.
- •Has electronic implants, such as Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant.
- •Is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area.
- •Has nerve insensitivity to heat in the treatment area or in the neutral pad placement area.
- •Is allergic to topical anesthetic
结局指标
主要结局
Maximum pain reported during treatment.
时间窗: procedure (during device treatment)]
The maximum pain during treatment per each device will be reported on a scale of 0(none) to 10 (maximum intolerable pain). This pain is recorded during when the patient is actively treated (when the patient comes in and receives a treatment from the device).
次要结局
未报告次要终点
研究者
研究点 (2)
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