An Observational Study to Assess Objective Skin Pigmentation Variation.

NCT ID: NCT07091604

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-22
• Study Completion Date: 2027-01-22

Brief Summary

Accurate assessment of skin pigmentation is essential in dermatology for properly diagnosing and managing a wide range of skin conditions. Traditionally, skin colour has been evaluated through visual inspection or by using classifications like the Fitzpatrick skin type. However, these methods can be subjective, culturally biased, and often are centered around lighter skin tones, which may lead to misdiagnosis or inappropriate treatment for individuals with darker skin.

With advances in technology, non-invasive imaging tools such as colorimetry and multispectral imaging now offer more precise and objective ways to measure skin pigmentation. These methods can help provide consistent and unbiased information about skin tone, benefiting both clinical care and research. Despite these technological advances, there is currently no agreed-upon standard for how to measure skin pigmentation objectively in everyday clinical practice or research settings.

This study aims to explore better, more accurate ways to measure skin pigmentation using modern, non-invasive imaging technologies. Traditional methods for assessing skin colour, like visual inspection or classifying by ethnicity, are often unreliable and biased. In this study, researchers will use tools such as colorimetry and multispectral imaging to measure skin pigmentation more objectively.

The study includes two groups of participants: healthy adults and adults with skin conditions. Researchers will measure a value called the melanin index, which reflects the amount of pigment in the skin, and compare it across different areas of the body and among people with different skin tones and conditions.

The goal is to understand how skin pigmentation varies and to see if these new technologies can help doctors more accurately diagnose and manage skin diseases for people of all skin types.

Conditions

Skin Diseases; Healthy Skin

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

Healthy volunteers with diverse skin tones

No interventions assigned to this group

Patients

Any patient with a skin condition under treatment by a dermatologist with active lesions.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Ability to understand oral and written Dutch or English

Exclusion Criteria

For study cohort #1 (Healthy volunteers):

• Extensive tattoos covering >50% of the total body area
• Recent extensive sun exposure (e.g. sun tanning booth or stay in a tropical country) in the last 3 weeks
• Use of self-tanner products in the last 3 weeks

For study cohort #2 (Patients):

• Extensive tattoos covering >50% of the total body area
• Extensive skin lesions covering >50% of the total body area
• Recent extensive sun exposure (e.g. sun tanning booth or stay in a tropical country) in the last 3 weeks
• Use of self-tanner products in the last 3 weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

dmwbalak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leiden University Medical Center

Leiden, Leiden, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Deepak M.W. Balak

Role: CONTACT

d.m.w.balak@lumc.nl

+31715296273

Lotte J. van den Oord

Role: CONTACT

l.j.van_den_oord@lumc.nl

+31611164067

Facility Contacts

Deepak M.W. Balak

Role: primary

d.m.w.balak@lumc.nl

+31715296273

Other Identifiers

NL-009794

Identifier Type: -

Identifier Source: org_study_id