NCT06654102已完成不适用
A Controlled, Single Center Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A (UVA) +/- High-Energy Visible (HEV) Blue Light Exposure
Johnson & Johnson Consumer Inc. (J&JCI)2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年10月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Pigmentation level as determined by clinical evaluation
研究概览
简要总结
The objective of this study is to assess the level of pigmentation following an acute exposure of skin to light regimens representative of portions of the natural sunlight spectrum and that contain Deep UVA wavelengths with or without HEV Blue Light, as compared to non-irradiated control skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Uniform skin color over the whole test area (the lower back) with minimal variation between test sites.
- •At least 3 subjects per skin type, as defined by self-reported reaction to sun exposure and Chromameter measurements.
- •Generally in good health.
- •Able to read, write, speak, and understand English.
- •Intends to complete the study and is willing and able to follow the subject responsibilities.
排除标准
- •In another study without approval by the study site.
- •Has known allergies or negative reactions to common topical skincare products or UV light.
- •Has a history of abnormal responses to sunlight or UV radiation.
- •Has used a tanning bed/lamp, has had extended sun exposure of the test area, or has participated in a UV exposure study within the past 4 weeks.
- •Has a current illness/condition/situation, a medical history of a disease/condition, or a skin condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, etc.) that could confuse the study results, interfere with participation, or increase health risk to the subject, as determined by the study investigator.
- •Has shaved/waxed the test area within 2 weeks before Visit
- •Has used any products in the test area within 24 hours before Visit
- •Has sunburn, suntan, scars, tattoos, active dermal lesions, nevi, or other conditions in the test area that could confuse the study results or increase health risk to the subject, as determined by the study investigator.
- •Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
- •Is immunosuppressed (such as HIV-positive, transplant patients, undergoing chemotherapy or radiotherapy, etc.).
- •Has been using a product or medication that the study investigator determines will increase health risk to the subject or confuse the study results
- •Has a personal or family history of skin cancer.
- •Skeletal protrusions and/or extreme areas of curvature in the test area.
- •Is pregnant, nursing, or planning to become pregnant.
- •Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
结局指标
主要结局
Pigmentation level as determined by clinical evaluation
时间窗: 15 mins and 18-22 hours Post-Irradiation
The subsites of each test site will be graded for immediate or persistent pigmentation darkening (IPD/PPD) by a trained evaluator using a 0-2 grading scale, where 0 = no pigmentation darkening and 2 = moderate to intense pigmentation darkening.The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2.
次要结局
- Pigmentation response as quantified by imaging(Baseline, 15 mins and 18-22 hours Post-Irradiation)
- Pigmentation response as quantified by Chromameter(Baseline, 15 mins and 18-22 hours Post-Irradiation)
研究者
研究点 (2)
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