Skin TypesNCT05657665
Skin Tone Measurement Method Investigation for Pulse Oximetry
An observational study of Skin Types and Pulse Oximetry, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Skin Types, Pulse Oximetry
- What is being tested?
- Observational measurements of skin tone
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Feb 2023to 11 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- Adult, Older adult
Study population: Healthy volunteers with Von Luschan scores <18 ('light skin' group) or > 25 ('dark skin' group.
Who may be able to join
- 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).
Who cannot join
- 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
- COVID-19 exclusion criteria*:
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Skin tone bias in pulse-oximetry (SpO2) needs to be addressed urgently. While skin pigmentation is a prime candidate for the root cause of skin tone bias in SpO2, more research is needed. F A solid comparison and recommendation requires evaluation of several additional aspects that affect accuracy, precision, and reproducibility of the PMMs.
Briefly, these additional aspects that are evaluated in this study are listed below:
- operator bias
- impact of operator color blindness
- probe pressure
- probe aperture size
- device stability
- impact of blood on pigmentation measurement
- feasibility of skin tone measurement on sides of fingers
- intra-operator variability
PMMs included in this study are:
Subjective color matching methods by using:
- Von Luschan color scale
- Fitzpatrick color scale
- Pantone color scale
Objective probe-based measurements by using:
- Konica Minolta CM700d (reflectance spectrometer)
- Mx18 (erythema-melanin meter)
- SPA99 (erythema-melanin meter)
Measurements will be performed on 5 relatively light skinned, and 5 relatively dark skinned volunteers (N=10 in total*). The study will be executed on the High-Tech Campus Eindhoven (Netherlands) and each participant will have 3 visits of approximately 1.5 to 2 hours/visit.
- Conditions
- Skin Types, Pulse Oximetry
- Being tested
- Observational measurements of skin tone
- Keywords
- Skin types, Pulse oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational measurements of skin toneOther
Objective and subjective skin tone measurements will be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start6 Feb 2023
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TypesStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657665
- Sponsor's protocol ID
- ICBE-S-000880
- Status last verified
- Apr 2023
- First submitted
- 12 Dec 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to perform data analysis by Philips Research. Thereafter data will be shared (de-identified) in a seperate publication that can be accessed overall.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Tone Measurement Method Investigation for Pulse Oximetry
- ClinicalTrials.gov ID
- NCT05657665
- Acronym / sponsor ID
- ICBE-S-000880
- Conditions
- Skin Types, Pulse Oximetry
- Keywords
- Skin types, Pulse oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Skin tone bias in pulse-oximetry (SpO2) needs to be addressed urgently. While skin pigmentation is a prime candidate for the root cause of skin tone bias in SpO2, more research is needed. F A solid comparison and recommendation requires evaluation of several additional aspects that affect accuracy, precision, and reproducibility of the PMMs.
Briefly, these additional aspects that are evaluated in this study are listed below:
- operator bias
- impact of operator color blindness
- probe pressure
- probe aperture size
- device stability
- impact of blood on pigmentation measurement
- feasibility of skin tone measurement on sides of fingers
- intra-operator variability
PMMs included in this study are:
Subjective color matching methods by using:
- Von Luschan color scale
- Fitzpatrick color scale
- Pantone color scale
Objective probe-based measurements by using:
- Konica Minolta CM700d (reflectance spectrometer)
- Mx18 (erythema-melanin meter)
- SPA99 (erythema-melanin meter)
Measurements will be performed on 5 relatively light skinned, and 5 relatively dark skinned volunteers (N=10 in total*). The study will be executed on the High-Tech Campus Eindhoven (Netherlands) and each participant will have 3 visits of approximately 1.5 to 2 hours/visit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers with Von Luschan scores <18 ('light skin' group) or > 25 ('dark skin' group.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (16 listed)
- Skin conditions that could potentially interfere with the measurements:
- COVID-19 exclusion criteria*:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational measurements of skin toneObjective and subjective skin tone measurements will be performed. | Other | – |
Primary outcome
Preferred skin PMM in the context of pulse-oximetry.
Time frame: 10 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No. The plan is to perform data analysis by Philips Research. Thereafter data will be shared (de-identified) in a seperate publication that can be accessed overall.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Types and Pulse Oximetry, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferred skin PMM in the context of pulse-oximetry. (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.