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NCT Number: NCT04270903

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Université catholique de Louvain

Brussels, 1200, Belgium

About this study

Electron paramagnetic resonance (EPR), also known as electron spin resonance (ESR), is a spectrometric method enabling the observation of the absorption of energy by the free radicals contained by a sample immerged in a strong homogenous magnetic field. An EPR spectrum reveals only the presence of paramagnetic centers and can thus only be observed with samples containing lone unpaired electrons. In water-containing biological environments, most of free radicals are very reactive and have a very short life. To detect such species, a strategy is to use extrinsic molecules that will react with these species to form EPR measurable adducts. This technique is called "spin trapping". In contrast, the study of stable free radicals does not require the use of spin-trap agents. Melanins are part of the rare stable biological radicals directly observable with EPR. In practice, melanin is the only endogenous stable radical that can be detected using 1 GHz EPR.

The aim of the present study is to measure the EPR signal recorded from skin with different pigmentations. 45 healthy volunteers will be enrolled:

15 subjects with phototype 1-2, 15 subjects with phototypes 3-4, 15 subjects with phototypes 5-6. The parameters described hereafter will be investigated:

  • g factor (resonance condition); expected g=2.005;
  • shape of the signal, presence of a shoulder at g=2.01 due to pheomelanin;
  • intensity of the signal (signal height, double integration, double integration relative to reference).

This will provide a database for other ongoing studies carried out in patients with suspicious lesion (nevi vs melanoma)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Measurement of the EPR signal intensity

    Time frame: Through study completion (6 months)

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

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2020
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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