Determination of the Minimal Dose of Visible Light Required to Achieve Immediate Pigment Darkening, Persistent Pigment Darkening, and Delayed Tanning for Fitzpatrick Skin Types IV-VI Utilizing Two Visible Light Sources.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Measurement of pigmentation changes induced by the two light sources using Colorimetry
研究概览
简要总结
The purpose of this study is to learn more about the potential effects of visible light on the skin. More specifically, this study will examine whether an incandescent lamp (light bulb) or LED light bulb can cause skin to become darker. Investigators will determine the minimum threshold dose required to achieve immediate pigmentation darkening (IPD), persistent pigmentation darkening (PPD), and delayed tanning (DT) for Fitzpatrick skin types IV - VI utilizing two visible light sources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a healthy volunteer with Fitzpatrick skin types I-VI;
- •Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection;
- •Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
- •Agree to follow and undergo all study-related procedures.
排除标准
- •Women who are lactating, pregnant, or planning to become pregnant;
- •Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post-inflammatory hyperpigmentation;
- •Patients with a known history of photosensitivity disorders;
- •Photosensitizing medications may be continued throughout of the study at the discretion of the investigator ;
- •Patients with a known history of melanoma or non-melanoma skin cancers;
- •Concomitant use of tanning beds;
- •Sun exposure of the irradiated or control areas;
- •Patients with serious systemic disease.
- •Patients with a known history of hypersensitivity to adhesives including adhesive tape.
研究组 & 干预措施
Healthy volunteers
Healthy volunteers without cutaneous disorders associated with pigmentary changes
干预措施: Part A: Baseline-Week 2 (Other)
Healthy volunteers
Healthy volunteers without cutaneous disorders associated with pigmentary changes
干预措施: Part B: Week 4-Week 12 (Other)
结局指标
主要结局
Measurement of pigmentation changes induced by the two light sources using Colorimetry
时间窗: 12 weeks
Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin
时间窗: 12 weeks
Measurement of pigmentation changes induced by the two light sources using Cross-Polarized Digital Photography
时间窗: 12 weeks
Quantification of the scattering and absorption properties of the skin in which the beam of light will penetrate using DRS
时间窗: 12 weeks
Measurement of pigmentation changes induced by the two light sources using diffuse reflectance spectrometer
时间窗: 12 weeks
次要结局
未报告次要终点