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.

Study Overview

• Status: Completed
• Conditions: Skin Pigmentation; Free Radicals; Phototype; Magnetic Resonance
• Intervention / Treatment: Device: EPR measurement

Detailed Description

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)

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Université Catholique de Louvain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phototype I - II; EPR measurement at the surface of the skin (arm)	Device: EPR measurement; 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 III - IV; EPR measurement at the surface of the skin (arm)	Device: EPR measurement; 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 V - VI; EPR measurement at the surface of the skin (arm)	Device: EPR measurement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the EPR signal intensity	Signal height / Double integration / Double integration relative to reference signal	Through study completion (6 months)

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: Bernard Gallez, PhD, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Actual): September 17, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MELA-RPE-PHOTOTYPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No