Skin PigmentNCT06144541
Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type
An observational study of Skin Pigment, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The purpose of this study is to correlate subjective skin pigment measurements as reported by patient-responses to the Fitzpatrick Skin Type Scale versus objective classification of skin pigment utilizing Individual Typology Angle (ITA) measurements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Pigment
- What is being tested?
- Survey administration for Fitzpatrick skin type and Measurement of ITA based on SkinColorCatch instrument
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2023to May 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects, healthy and unhealthy, are eligible to enroll. Subjects from the greater Sacramento region will be enrolled. Subjects must be at least 18 years of age.
Who may be able to join
- Male and females that are 18 years of age and older
- Subjects with all Fitzpatrick skin types I-VI One-third of subjects will be Fitzpatrick I or II skin types, one-third of subjects will be III or IV, and one-third will have V and VI.
Who cannot join
- Individuals who are pregnant or breastfeeding.
- Prisoners
- Adults unable to consent
- Individuals with open wounds on the nondominant upper inner arm
- Individuals with fibrotic skin disease or other skin conditions or hair growth on the nondominant upper inner arm that could affect skin measurements in the opinion of the investigator
- Individuals with tattoos that cover the site on the nondominant upper inner arm
Show all 9Show fewer
- Individuals with post-inflammatory hypopigmentation or hyperpigmentation
- Individuals with vitiligo
- Individuals who have used self-tanning products or tanning beds in the last two weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Skin Science & Research
Sacramento, California, 95815
Raja Sivamani, MD MS AP
Raja Sivamani, MD MS AP
About this study
The purpose of this study is to correlate subjective skin pigment measurements as reported by patient-responses to the Fitzpatrick Skin Type Scale versus objective classification of skin pigment utilizing Individual Typology Angle (ITA) measurements.
Read the detailed description
The Fitzpatrick scale is a numerical classification for human skin color developed in 1975 as a way to estimate the response of different types of skin to UV light. It is used by dermatologists to classify skin tone and assess the risk of skin cancer.
The Fitzpatrick scale encompasses six gradings, from I to VI. However, this does not include all skin tones, as there are significantly more not encompassed within the scale. The aim of this study is to incorporate objective measurements when identifying a patient's Fitzpatrick skin type.
- Conditions
- Skin Pigment
- Being tested
- Survey administration for Fitzpatrick skin type, Measurement of ITA based on SkinColorCatch instrument
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey administration for Fitzpatrick skin typeOther
Survey administration for Fitzpatrick skin type
Measurement of ITA based on SkinColorCatch instrumentDevice
Measurement of ITA based on SkinColorCatch instrument
| Study group | Role | What they receive |
|---|---|---|
| General public | This survey and ITA measurements will be performed among the general public Receives: Other: Survey administration for Fitzpatrick skin type; Device: Measurement of ITA based on SkinColorCatch instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type
Correlation of ITA by the use of SkinColorCatch (Delfin) compared to the Fitzpatrick skin scale as determined by the patients' responses to validated questionnaire.
The higher the ITA, the lighter the skin. ITA skin color types are classified into six groups, from Very Light to Dark skin.
Measured: One time - collected for up to 1 year for the entire study
Secondary outcomes (2)
Assess Fitzpatrick Skin type based on validated questionnaire
Questionnaire about sun sensitivity and tanning will be administered to calculate the Fitzpatrick skin types
Measured: One time - collected for up to 1 year for the entire study
Sun protection habit use
Quantification of sun protection habits based on survey question asking their typical use of sun protection
Measured: One time - collected for up to 1 year for the entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start21 Nov 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PigmentStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144541
- Sponsor's protocol ID
- i23-09_Fitz_Skin
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type
- ClinicalTrials.gov ID
- NCT06144541
- Acronym / sponsor ID
- i23-09_Fitz_Skin
- Conditions
- Skin Pigment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 22 Nov 2023 (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 purpose of this study is to correlate subjective skin pigment measurements as reported by patient-responses to the Fitzpatrick Skin Type Scale versus objective classification of skin pigment utilizing Individual Typology Angle (ITA) measurements.
Detailed description
The Fitzpatrick scale is a numerical classification for human skin color developed in 1975 as a way to estimate the response of different types of skin to UV light. It is used by dermatologists to classify skin tone and assess the risk of skin cancer.
The Fitzpatrick scale encompasses six gradings, from I to VI. However, this does not include all skin tones, as there are significantly more not encompassed within the scale. The aim of this study is to incorporate objective measurements when identifying a patient's Fitzpatrick skin type.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General public | – | Other: Survey administration for Fitzpatrick skin type, Device: Measurement of ITA based on SkinColorCatch instrumentThis survey and ITA measurements will be performed among the general public |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects, healthy and unhealthy, are eligible to enroll. Subjects from the greater Sacramento region will be enrolled. Subjects must be at least 18 years of age.
Key inclusion criteria (2 listed)
- Male and females that are 18 years of age and older
- Subjects with all Fitzpatrick skin types I-VI One-third of subjects will be Fitzpatrick I or II skin types, one-third of subjects will be III or IV, and one-third will have V and VI.
Key exclusion criteria (9 listed)
- Individuals who are pregnant or breastfeeding.
- Prisoners
- Adults unable to consent
- Individuals with open wounds on the nondominant upper inner arm
- Individuals with fibrotic skin disease or other skin conditions or hair growth on the nondominant upper inner arm that could affect skin measurements in the opinion of the investigator
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 |
|---|---|---|
| Survey administration for Fitzpatrick skin typeSurvey administration for Fitzpatrick skin type | Other | General public |
| Measurement of ITA based on SkinColorCatch instrumentMeasurement of ITA based on SkinColorCatch instrument | Device | General public |
Primary outcome
Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type
Time frame: One time - collected for up to 1 year for the entire study
Correlation of ITA by the use of SkinColorCatch (Delfin) compared to the Fitzpatrick skin scale as determined by the patients' responses to validated questionnaire. The higher the ITA, the lighter the skin. ITA skin color types are classified into six groups, from Very Light to Dark skin.
2 secondary outcomes
Assess Fitzpatrick Skin type based on validated questionnaire
Time frame: One time - collected for up to 1 year for the entire study
Sun protection habit use
Time frame: One time - collected for up to 1 year for the entire study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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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.
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 Pigment, run by Integrative Skin Science and Research at 1 site in United States.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Nov 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja Sivamani, MD (916-524-1216, raja.sivamani@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type (time frame: One time - collected for up to 1 year for the entire study). 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 28 Nov 2023.