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CTRI Number  CTRI/2025/03/082814 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 01/07/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective cross sectional study 
Study Design  Other 
Public Title of Study   A study on skin color variations across different populations 
Scientific Title of Study   Global characterization of skin color 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
901116_Version 1.1 dated 10.02.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Reshma Ambulkar  
Designation  Professor and Head 
Affiliation  Tata Memorial Centre  
Address  Department of Anaesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Reshma Ambulkar  
Designation  Professor and Head 
Affiliation  Tata Memorial Centre  
Address  Department of Anaesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com   
 
Details of Contact Person
Public Query
 
Name  Reshma Ambulkar  
Designation  Professor and Head 
Affiliation  Tata Memorial Centre  
Address  Department of Anaesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com   
 
Source of Monetary or Material Support  
195 Montague Street, 14th Floor, Brooklyn, NY 11201, USA 
 
Primary Sponsor  
Name  Lifebox foundation  
Address  195 Montague Street, 14th Floor, Brooklyn, NY 11201, USA  
Type of Sponsor  Other [Non Profit Organisation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reshma Ambulkar  Advanced Centre for Treatment, Research and Education in Cancer  Department of Anaesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA 
9821790448

rambulkar@hotmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre Institutional Ethics Committee III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  skin color/ pigmentation variations 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NIL 
Comparator Agent  NA  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age more than 18 years
2. Healthy volunteers from the target population
 
 
ExclusionCriteria 
Details  1. 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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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) 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 

 
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