Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Correct Identification of Baseline Photographs vs. Photographs Taken 3 Months Post Last Treatment
研究概览
简要总结
The intended use of the PicoSure device with focus lens array used in this study is to assess images to support additional marketing claims for the treatment of pigmentation and mild to moderate wrinkles.
详细描述
Up to 10 subjects will be enrolled at 1 study center. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face with the PicoSure device.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A healthy male or female 18 - 65 years of age.
- •Willing to undergo treatments for pigmentation and/or mild to moderate wrinkles on the face with the PicoSure device.
- •Understands and accepts obligation not to receive any other procedures on 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 pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- •The subject is hypersensitive to light in the near infrared wavelength region.
- •The subject takes medication which is known to increase sensitivity to sunlight.
- •The subject has seizure disorders triggered by light.
- •The subject takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
- •The subject has an active localized or systemic infection, or an open wound in area being treated.
- •The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.
- •The subject has common acquired nevi that are predisposed to the development of malignant melanoma.
- •The subject has herpes simplex in the area being treated.
- •The subject is receiving or has received gold therapy.
- •The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study.
- •The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
结局指标
主要结局
Correct Identification of Baseline Photographs vs. Photographs Taken 3 Months Post Last Treatment
时间窗: 3 month follow up
Three blinded independent reviewers will perform a photographic evaluation in which they will be asked to identify pre-treatment images when compared to post treatment images. The percentage of photographs that were correctly identified as either baseline photographs or photographs taken at the 3 month follow up will be reported. Identifying whether the photograph was taken at the baseline vs. 3 month follow up was only done at the 3 month follow up point.
次要结局
未报告次要终点