Skin Tone Measurement Method Investigation for Pulse Oximetry

NCT05657665 | Completed

• 1 other identifier: ICBE-S-000880
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to gather missing information in order to form a well-founded recommendation on which is the preferred skin pigmentation measurement (PPM) methods in the context of pulse-oximetry.

Conditions

Skin Types; Pulse Oximetry

Keywords

Skin types; Pulse oximetry

Outcome Measures

Primary Outcomes (1)

• Preferred skin PMM in the context of pulse-oximetry.

  The primary objective is to complement a previous skin pigmentation study executed by Philips to gather missing information in order to form a well-founded recommendation on which is the preferred skin PPM in the context of pulse-oximetry.

  10 months

Interventions

Observational measurements of skin tone OTHER

Objective and subjective skin tone measurements will be performed.

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers with Von Luschan scores \<18 ('light skin' group) or \> 25 ('dark skin' group.

You may qualify if:

• Adults (18-65 years)
• Fluent in either English or Dutch
• Participants who are willing and able to provide informed consent themselves.
• People with Von Luschan scores \<18 ('light skin' group) or \> 25 ('dark skin' group).

You may not qualify if:

• Skin conditions that could potentially interfere with the measurements:
• piercings/ink/henna tattoos that cover the left forearm, hands, fingers or forehead
• vascular or pigmentary or renal psoriasis
• epidermal bullosum
• other diseases that affect the skin (tone) of the body
• Currently displaying COVID-19-related symptoms, namely a fever, cough and/or difficulty breathing
• Having been positively tested as infected with COVID-19 in the past 14 days
• Travelled to or from high risk COVID-19 areas in the past 14 days
• Been in contact with a (suspected) COVID-infected person in the past 14 days
• Not being able to travel to Eindhoven 3 times, and/or not being able to comply with the study procedures
• Sunbathing during the study duration or substantial sun exposure (due to holidays for example).
• Known allergic reaction to facial make-up
• Usage of tanning sprays/cremes
• Wearing make-up during the study visits (mascara is allowed)
• No testing will be performed in the study. Participants will be asked if they have been positively tested.

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead

Study Sites (1)

High Tech Campus

Eindhoven, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: February 6, 2023
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)