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Normative Data of Intra-epidermal Nerve Fiber Density

Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01498211
Enrollment
300
Registered
2011-12-23
Start date
2011-12-31
Completion date
2014-05-31
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

volunteer

Brief summary

Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population. To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.

Interventions

PROCEDUREBiopsy

3 mm punch biopsy of the skin at the distal leg.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Man or woman between 20-80 years old * Normal subjects without pain and neurological impairment * No history of neurological disorder * Normal neurological examination * Normal ECG * Normal clotting sample from less than 6 months * Available by phone

Exclusion criteria

: * History of alcoholic intoxication or chemotherapy * History of diabetes, kidney insufficiency, monoclonal gammapathy, B/C hepatitis, HIV, coeliac disease, sicca syndrome, raynaud syndrome, systemic erythematous lupus, Fabry disease, amylosis, vascularitis * Contraindication to xylocaïn with adrenalin * At the site of biopsy : surgery, skin pathology, infection, vascular insufficiency * Innate or acquired immunosuppression * Innate or acquired clotting abnormality

Design outcomes

Primary

MeasureTime frame
Measure density of intraepidermic nervous fibres by optical and electronic microscopy in a population of healthy witnesses according to the age and the sex.1 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026