跳至主要内容
临床试验/CTRI/2025/03/082814
CTRI/2025/03/082814尚未招募不适用

Global characterization of skin color

Lifebox foundation1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
1
主要终点
To quantify the wide range of human skin color grades by the use of a colorimeter in India.

研究概览

简要总结

Many medical devices, like thermometers, pulse oximeters, and heart rate monitors, use light to measure important health indicators non-invasively. However, research has shown that these devices may not work as well on people with darker skin, potentially leading to health disparities. One reason is that these devices were often tested primarily on people with lighter skin, and current testing standards do not adequately account for different skin tones. For example, pulse oximeters are only required to test a small number of people with darker skin, but there are no clear guidelines on how to define or measure "dark skin."

This study aims to address this issue by better understanding how devices perform across a wide range of skin colors, particularly in diverse populations like those in India. The study will use both subjective methods (like skin tone scales) and objective methods (like colorimeters, which measure skin color more precisely) to categorize skin tones. It will also explore whether low-cost color measurement devices can be as accurate as expensive ones, which could improve access to accurate healthcare in resource-limited settings.

The goal is to provide more accurate data on skin tone diversity to help improve the design, testing, and regulation of medical devices, ensuring that everyone, regardless of skin color, receives the same level of care.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age more than 18 years
  • Healthy volunteers from the target population.

排除标准

  • Patients undergoing active treatment at the study site
  • Extensive dermatological or pigmentation disorder that may interfere with skin color measurement with the colorimeter
  • Extensive tattooing at proposed skin tone measurement sites that may interfere with measurements
  • Extensive scarring, burns, lesions, moles, or injuries at proposed skin tone measurement sites.

结局指标

主要结局

To quantify the wide range of human skin color grades by the use of a colorimeter in India.

时间窗: A single time point assessment of skin tone in healthy individuals by means of colorimeter and skin tone scales(Monk and Pantone)

次要结局

  • To assign objective measurement ranges to different skin color grades represented on currently validated subjective skin tone scales by the use of a colorimeter(objective).(A single time point assessment of skin tone in healthy individuals by means of colorimeter & skin tone scales(Monk & Pantone))

研究者

发起方
Lifebox foundation
申办方类型
Other [Non Profit Organisation]

研究点 (1)

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