Skin PigmentationNCT04270903
EPR (Electron Paramagnetic Resonance) as Method of Non-invasive Characterization of Melanin Content in Skins With Different Phototypes
An observational study of Skin Pigmentation and Free Radicals, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Pigmentation, Free Radicals, Phototype
- What is being tested?
- EPR measurement
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Mar 2019to 20 Dec 2019
- 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: 45 healthy volunteers * 15 subjects with skin Phototype I-II * 15 subjects with Phototype III-IV * 15 subjects with Phototype V-VI
Who may be able to join
- Healthy volunteers with skin belonging to Phototype I-II, III-IV, V-VI
Who cannot join
- Subjects under 18 years
- Subjects with pacemakers
- Subjects with non-removable implants with metal or otherwise not known to be MRI-compatible.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Skin Pigmentation, Free Radicals, Phototype, Magnetic Resonance
- Being tested
- EPR measurement
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPR measurementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Phototype I - II | EPR measurement at the surface of the skin (arm) Receives: Device: EPR measurement | |
| Phototype III - IV | EPR measurement at the surface of the skin (arm) Receives: Device: EPR measurement | |
| Phototype V - VI | EPR measurement at the surface of the skin (arm) Receives: Device: EPR measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the EPR signal intensity
Signal height / Double integration / Double integration relative to reference signal
Measured: Through study completion (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start22 Mar 2019
- Primary completion17 Sep 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PigmentationStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Gallez, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270903
- Sponsor's protocol ID
- MELA-RPE-PHOTOTYPE
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPR (Electron Paramagnetic Resonance) as Method of Non-invasive Characterization of Melanin Content in Skins With Different Phototypes
- ClinicalTrials.gov ID
- NCT04270903
- Acronym / sponsor ID
- MELA-RPE-PHOTOTYPE
- Conditions
- Skin Pigmentation, Free Radicals, Phototype, Magnetic Resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 17 Feb 2020 (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 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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phototype I - II | – | Device: EPR measurementEPR measurement at the surface of the skin (arm) |
| Phototype III - IV | – | Device: EPR measurementEPR measurement at the surface of the skin (arm) |
| Phototype V - VI | – | Device: EPR measurementEPR measurement at the surface of the skin (arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 45 healthy volunteers * 15 subjects with skin Phototype I-II * 15 subjects with Phototype III-IV * 15 subjects with Phototype V-VI
Key inclusion criteria (1 listed)
- Healthy volunteers with skin belonging to Phototype I-II, III-IV, V-VI
Key exclusion criteria (4 listed)
- Subjects under 18 years
- Subjects with pacemakers
- Subjects with non-removable implants with metal or otherwise not known to be MRI-compatible.
- Pregnant women
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 |
|---|---|---|
| EPR measurementSubject 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. | Device | Phototype I - II, Phototype III - IV, Phototype V - VI |
Primary outcome
Measurement of the EPR signal intensity
Time frame: Through study completion (6 months)
Signal height / Double integration / Double integration relative to reference signal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Skin Pigmentation
Active, not recruiting
Plasma Exeresis Plus NB-UVB Versus NB-UVB Alone for Stable Vitiligo
Vitiligo
Enrolling by invitation
Topical Ruxolitinib Versus Tacrolimus With Excimer Laser for Localized Vitiligo
Vitiligo, Nonsegmental Vitiligo
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Evaluation of Crisaborole 2% Versus Tacrolimus 0.1% Each Combined With Excimer Light in the Treatment of Stable Non-segmental Facial Vitiligo: a Prospective Randomized Controlled Study.
Vitiligo, Non-Segmental Vitiligo (NSV)
Not yet recruitingObservational study
Chinese Multicenter Registry for Peutz-Jeghers Syndrome
Peutz-Jeghers Syndrome
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.
Bernard Gallez, PhD principal investigator
Université Catholique de Louvain
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 Pigmentation and Free Radicals, run by Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 17 Feb 2020. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the EPR signal intensity (time frame: Through study completion (6 months)). 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 17 Feb 2020.