EPR (Electron Paramagnetic Resonance) as Method of Non-invasive Characterization of Melanin Content in Skins With Different Phototypes

NCT04270903 | Completed

• 1 other identifier: MELA-RPE-PHOTOTYPE
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the signal of melanin using Electron Paramagnetic resonance (EPR). Melanin is a paramagnetic pigment detectable by EPR. Recent advances in instrumentation allows the application of EPR in human beings. The characterization of melanin by EPR could be potentially interesting in the context of melanoma detection and characterization. While another clinical study is currently ongoing aiming at demonstrating the feasibility of the non-invasive detection of the EPR signal of melanin in melanoma patients, it is crucial to have a control group with healthy skin. The aim of the present study is to assess the influence of skin pigmentation of the EPR signal recorded. In the present clinical study, the EPR signal of melanin will be characterized in healthy skin with different phototypes (1-2, 3-4, 5-6) to assess the potential influence of skin pigmentation on the EPR signal.

Conditions

Skin Pigmentation; Free Radicals; Phototype; Magnetic Resonance

Outcome Measures

Primary Outcomes (1)

• Measurement of the EPR signal intensity

  Signal height / Double integration / Double integration relative to reference signal

  Through study completion (6 months)

Study Arms (3)

Phototype I - II

EPR measurement at the surface of the skin (arm)

Device: EPR measurement

Phototype III - IV

EPR measurement at the surface of the skin (arm)

Device: EPR measurement

Phototype V - VI

EPR measurement at the surface of the skin (arm)

Device: EPR measurement

Interventions

EPR measurement DEVICE

Subject put in a magnet, magnetic field sweeping around 40 mTesla. Irradiation with a wave with a frequency of 1.1 GHz. A resonator (surface coil) is put at the surface of the skin (arm). The EPR signal is recorded.

Phototype I - II; Phototype III - IV; Phototype V - VI

Eligibility Criteria

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

Study Population

45 healthy volunteers * 15 subjects with skin Phototype I-II * 15 subjects with Phototype III-IV * 15 subjects with Phototype V-VI

You may qualify if:

• Healthy volunteers with skin belonging to Phototype I-II, III-IV, V-VI

You may not qualify if:

• Subjects under 18 years
• Subjects with pacemakers
• Subjects with non-removable implants with metal or otherwise not known to be MRI-compatible.
• Pregnant women

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Université catholique de Louvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernard Gallez, PhD

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: March 22, 2019
• Primary Completion: September 17, 2019
• Study Completion: December 20, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)