| 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
|
|
|
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
|
|
|
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. |