Clinical trial Recruiting at 1 site Interventional Ages 18 and up

How exposure to heavy metals, nanoparticles, and emerging contaminants relates to allergic skin and systemic metal reactions

Official title: Model of diseAses Related to Environmental Exposure to Heavy meTals, nanopaRticles and Emergent Contaminants, Using a dIgital platfOrm of Clinical and Bio-humoral Data: the Way to Susceptibility/RisK BiomArker [MATRIOSKA Study] - The Seed.

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06529913 · Data updated 2026-11-12

This project will test whether adults with allergic contact dermatitis or systemic metal allergies have different levels of heavy metals, nanoparticles, and related blood and urine markers compared with healthy adults.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment280 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations2 sites (Bologna and 1 other locations)
StatusRecruiting
StartedJanuary 13, 2025
Main results expectedSeptember 30, 2026
Study endsDecember 31, 2026
Registry record updatedFebruary 24, 2026
Trial IDNCT06529913 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (age ≥18) with allergic contact dermatitis due to metals or with systemic metal allergic syndrome, as well as healthy adult volunteers able to give written informed consent, are ideal candidates.

Probably not a fit

Individuals under 18, pregnant or breastfeeding women, patients with chronic renal failure requiring replacement therapy, those with other systemic metal-related diseases, or people with certain gastrointestinal or other skin diseases are excluded and unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will recruit three adult groups—patients with systemic metal allergic syndrome, patients with allergic contact dermatitis due to metals, and healthy controls—and collect environmental, biological, and clinical data. investigators will measure serum and urine concentrations of metals and nanoparticles, perform metal patch testing, record within-breath oscillometry parameters, and analyze serum zonulin and protein oxidation products. Environmental sampling and exposure histories will be obtained to link external exposures with biological markers. Results will be compared across the three groups to determine whether exposed patients show distinct biomarker or clinical profiles.

Why it matters

Potential benefit: If successful, this could identify exposure-related biomarkers that improve diagnosis, prevention, and management of metal-related allergic conditions.

How similar studies have gone: Prior research has established links between metal exposure and contact dermatitis, but combining nanoparticle measurements with zonulin and protein oxidation markers is relatively novel and not yet proven.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* adult subjects (over 18 years of age).
* Subjects suffering from allergic contact dermatitis due to metals.
* Subjects with systemic allergic syndrome due to metals.
* Adult healthy subjects.
* Subjects able to give written informed consent.

Exclusion Criteria:

* Subjects under the age of 18years.
* Pregnant/breastfeeding women.
* Subjects suffering from chronic renal failure requiring replacement treatment.
* Subjects suffering from other systemic pathologies related to exposure to metals.
* Subjects suffering from gastrointestinal diseases such as celiac disease, chronic inflammatory intestinal diseases, tumors, other skin diseases.
* Subjects unable to express written informed consent.

Where it's running

  • Fondazione Policlinico Universitario A. Gemelli IRCCS
    Roma, Italy
    Recruiting
  • Università di Bologna
    Bologna, Italy
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.