MedPath

A study on skin color variations across different populations

Not yet recruiting
Conditions
skin color/ pigmentation variations
Registration Number
CTRI/2025/03/082814
Lead Sponsor
Lifebox foundation
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
1000
Inclusion Criteria
  • Age more than 18 years 2.
  • Healthy volunteers from the target population.
Exclusion Criteria
  • Patients undergoing active treatment at the study site 2.
  • Extensive dermatological or pigmentation disorder that may interfere with skin color measurement with the colorimeter 3.
  • Extensive tattooing at proposed skin tone measurement sites that may interfere with measurements 4.
  • Extensive scarring, burns, lesions, moles, or injuries at proposed skin tone measurement sites.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To quantify the wide range of human skin color grades by the use of a colorimeter in India.A single time point assessment of skin tone in healthy individuals by means of colorimeter and skin tone scales(Monk and Pantone)
Secondary Outcome Measures
NameTimeMethod
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)

Trial Locations

Locations (1)

Advanced Centre for Treatment, Research and Education in Cancer

🇮🇳

Raigarh, MAHARASHTRA, India

Advanced Centre for Treatment, Research and Education in Cancer
🇮🇳Raigarh, MAHARASHTRA, India
Dr Reshma Ambulkar
Principal investigator
9821790448
rambulkar@hotmail.com

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