Skin Pigmentation Clinical Trial
Official title:
EPR (Electron Paramagnetic Resonance) as Method of Non-invasive Characterization of Melanin Content in Skins With Different Phototypes
Verified date | February 2020 |
Source | Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 20, 2019 |
Est. primary completion date | September 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Université catholique de Louvain | Brussels |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of the EPR signal intensity | Signal height / Double integration / Double integration relative to reference signal | Through study completion (6 months) |
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