How exposure to heavy metals, nanoparticles, and emerging contaminants relates to allergic skin and systemic metal reactions
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.
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (Bologna and 1 other locations) |
| Trial ID | NCT06529913 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna and 1 other locations
- Università di Bologna — Bologna, Italy (Not_yet_recruiting)
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Angela Rizzi, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Angela Rizzi, MD, PhD
- Email: angela.rizzi@policlinicogemelli.it
- Phone: +390630154952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.