AzTrials
AzTrials

Allergic Contact DermatitisMATRIOSKANCT06529913

Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases

A study testing Collection of environmental, biological, and clinical data in people with Allergic Contact Dermatitis and Metal Allergy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to collect environmental, bio-humoral, and clinical data derived from patients with allergic contact dermatitis (ACD) and systemic metal allergic syndromes related to the exposure to heavy metals, nanoparticles, and emergent contaminants and from healthy subjects. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Collection of environmental, biological, and clinical data
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
2 sitesItaly
Study dates
13 Jan 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Angela Rizzi, MD, PhD contact

+390630154952

angela.rizzi@policlinicogemelli.it

Michele Centrone, MD contact

+390630154952

michele.centrone@guest.policlinicogemelli.it

Italy2 sites, 2 recruiting

  • Università di Bologna

    Bologna, 40126

    Pierpaolo Palumbo, PhD, pierpaolo.palumbo@unibo.it

    Pierpaolo Palumbo, PhD

    Not yet recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168

    Angela Rizzi, MD, PhD, MSc, +390630154952, angela.rizzi@policlinicogemelli.it

    Michele Centrone, MD, +390630154952, michele.centrone@guest.policlinicogemelli.it

    Recruiting

Other trials in Italy

About this study

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.

The goal of this clinical trial is to collect environmental, bio-humoral, and clinical data derived from patients with allergic contact dermatitis (ACD) and systemic metal allergic syndromes related to the exposure to heavy metals, nanoparticles, and emergent contaminants and from healthy subjects.

The main question it aims to answer is: are environmental, bio-humoral, and clinical data derived from patients with ACD and systemic metal allergic syndromes, related to the exposure to heavy metals, nanoparticles, and emergent contaminants, different from ones obtained by healthy subjects? Researchers will compare serum and urine concentration of heavy metals and nanoparticles, patch test to metals, within-breath analysis of oscillometry parameters, serum zonulin, and serum levels of protein oxidation products among patients with systemic allergic syndrome (1st study group), patients with ACD (2nd study group) and healthy subjects (3rd study group).

Read more

Participants will undergo:

  • measurement of exposure to heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper, through serum and urine measurement of concentration.
  • Patch test to before mentioned metals.
  • Within-breath analysis of oscillometry parameters.
  • Measurement of serum zonulin (related to gastro-intestinal exposure).
  • Measurement of serum levels of protein oxidation products (as markers of systemic oxidative stress).
Read the detailed description

Heavy metals [nickel (Ni), cobalt (Co), chromium (Cr), palladium, molybdenum, aluminium, and copper] are environmental contaminants able to impact on host cells of humans and various organisms, potentially causing serious damage. These metals can be present also in form of nanoparticles.

Nanoparticles are tiny particles between 1 and 100 nanometres in size. Nanoparticles have applications in a wide range of fields, including medicine, electronics, energy, and environmental remediation. However, the potential environmental and health risks associated with nanoparticles are also focus of global research.

The research on metal allergies in exposed subjects is challenging since the exposures are common both at the workplace and outside.

Environmental exposures are important for development of allergic contact dermatitis (ACD).

ACD is a common skin disorder caused by contact with an exogenous substance that elicits a hypersensitivity response in susceptible individuals.

Among workers exposed to such irritants and allergens at work, ACD is a common occupational health problem with a significant incidence. According to the most recent scientific studies, the overall prevalence of ACD between 1996 and 2019 is estimated at 10.5 per cent.

In some individuals, the ingestion of Ni-rich foods causes systemic skin disorders (urticaria/angioedema, erythema, eczema) and extracutaneous multi-organ symptoms (heartburn, meteorism, abdominal pain, alvo, oral aphthosis, headache, respiratory disorders, recurrent infections, fibromyalgia), expressed singularly or in variable association in some particularly sensitive subjects. This clinical picture is known as Systemic Nickel Allergy Syndrome (SNAS), which occurs in approximately 20% of ACD individuals.

Researchers will collect environmental, bio-humoral, and clinical data derived from patients with ACD and systemic metal allergic syndromes related to the exposure to heavy metals, nanoparticles, and emergent contaminants, and compare with ones obtained from healthy subjects to identify susceptibility / risk factors for these diseases.

Patients with systemic allergic syndrome (1st study group) and patients with ACD (2nd study group) will undergo the measurement of exposure to heavy metals and nanoparticles including Ni, Co, Cr, palladium, molybdenum, aluminium, and copper. Furthermore, putative effect biomarkers (patch test to metals, within-breath analysis of oscillometry parameters, and serum zonulin, related to cutaneous, respiratory, and gastro-intestinal exposure, respectively, and serum levels of protein oxidation products, as markers of systemic oxidative stress) and exposure biomarkers (serum and urinary metal concentrations) will be researched in both groups. The same investigation will be conducted on healthy subjects (3rd study group).

Being tested
Collection of environmental, biological, and clinical data
Keywords
Metal Allergy, Nanoparticles, Emergent contaminants, Nickel, Aluminium, Copper, Chromium, Cobalt, Palladium, Titanium, Allergic Contact Dermatitis, Food Allergy, Functional Gastrointestinal Disorders, Respiratory Injury, Environmental Exposure, Patch test, Biomarkers
Medical subject headings
Dermatitis, Allergic Contact, Food Hypersensitivity, Eczema, Gastrointestinal Diseases, Environmental Illness, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of environmental, biological, and clinical dataDiagnostic test

    All enrolled patients/healthy volunteers will undergo:

    • measurement of serum and urine concentration of metals (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
    • Patch test to metals.
    • Within-breath analysis of oscillometry parameters.
    • Measurement of serum zonulin.
    • Measurement of serum levels of protein oxidation products.
Study groups in NCT06529913
Study groupRoleWhat they receive
Allergic contact dermatitis to metalsExperimentalPatients with allergic contact dermatitis due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
Receives: Diagnostic Test: Collection of environmental, biological, and clinical data
Systemic allergic syndromes to metalsExperimentalPatients with systemic allergic syndrome due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
Receives: Diagnostic Test: Collection of environmental, biological, and clinical data
Healthy volunteersExperimentalHealthy volunteers without metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
Receives: Diagnostic Test: Collection of environmental, biological, and clinical data

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum concentration of metals

    Measurement of serum concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.

    Measured: At enrollment.

  2. Urinary concentration of metals

    Measurement of urinary concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.

    Measured: At enrollment.

  3. Patch test

    Application of patch test with heavy metals including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.

    Patch tests will be evaluated 48h and 72h after their application and will be evaluated through a universally accepted grading system elaborated by The International Contact Dermatitis Research Group. The intensity will be assessed according to the following criteria:

    1. ± faint, non-palpable erythema;
    2. + palpable erythema;
    3. ++ strong infiltrate, numerous papules, and vesicles present strong reaction;
    4. +++ coalescing vesicles, bullae or ulceration, and an extreme erythematous reaction.

    Measured: At enrollment.

  4. Number of subjects with altered values of respiratory system impedance

    All patients and healthy volunteers will undergo oscillometry. Tidal breathing analysis with impulse oscillometry (IOS) has proven to be an informative and meaningful tool to characterize peripheral airways dysfunction.

    Measured: At enrollment.

  5. Serum concentration of zonulin

    Measurement of serum zonulin.

    Measured: At enrollment.

  6. Serum concentration of protein oxidation products

    Measurement of serum protein oxidation products as markers of systemic oxidative stress.

    Measured: At enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start13 Jan 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06529913
Sponsor's protocol ID
6628
Other IDs
PNC-PNRRDARE-PNC0000002
Acronym
MATRIOSKA
Status last verified
Feb 2026
First submitted
26 Jul 2024
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The Researchers intend to communicate the results of the trial to participants, healthcare professionals, and other relevant groups through scientific publications and national and international conference proceedings. No individual participant data will be shared. All publications resulting from this research project will bear the following wording "PNC Notice DD n. 931 of 6/06/2022 - Project PNC0000002 - "DARE - Digital Lifelong Prevention".

Publications

  • Rizzi A, Lo Presti E, Chini R, Gammeri L, Inchingolo R, Lohmeyer FM, Nucera E, Gangemi S. Emerging Role of Alarmins in Food Allergy: An Update on Pathophysiological Insights, Potential Use as Disease Biomarkers, and Therapeutic Implications. J Clin Med. 2023 Apr 4;12(7):2699. doi: 10.3390/jcm12072699.

    PubMed 37048784

  • Rizzi A, Chini R, Porcari S, Settanni CR, Persichetti E, Mora V, Fanali C, Leonetti A, Parrinello G, Lohmeyer FM, Inchingolo R, Mele MC, Gasbarrini A, Nucera E. Datterino Trial: A Double Blind, Randomized, Controlled, Crossover, Clinical Trial on the Use of Hydroponic Cultivated Tomato Sauce in Systemic Nickel Allergy Syndrome. J Clin Med. 2022 Sep 16;11(18):5459. doi: 10.3390/jcm11185459.

    PubMed 36143107

  • Nucera E, Rizzi A, Chini R, Giangrossi S, Lohmeyer FM, Parrinello G, Musca T, Miggiano GAD, Gasbarrini A, Inchingolo R. Diet Intervention Study through Telemedicine Assistance for Systemic Nickel Allergy Syndrome Patients during the COVID-19 Pandemic. Nutrients. 2021 Aug 23;13(8):2897. doi: 10.3390/nu13082897.

    PubMed 34445054

  • Rizzi A, Chini R, Inchingolo R, Carusi V, Pandolfi F, Gasbarrini A, Nucera E. Nickel allergy in lipid transfer protein sensitized patients: Prevalence and clinical features. Int J Immunopathol Pharmacol. 2020 Jan-Dec;34:2058738420974895. doi: 10.1177/2058738420974895.

    PubMed 33242297

  • Rizzi A, Di Rienzo A, Buonomo A, Aruanno A, Carusi V, Ricci AG, Centrone M, Mezzacappa S, Romeo L, Schiavino D, Inchingolo R, Gasbarrini A, Nucera E. Impact of nickel oral hyposensitization on quality of life in systemic nickel allergy syndrome. Int J Immunopathol Pharmacol. 2020 Jan-Dec;34:2058738420934629. doi: 10.1177/2058738420934629.

    PubMed 32567420

  • Rizzi A, Nucera E, Laterza L, Gaetani E, Valenza V, Corbo GM, Inchingolo R, Buonomo A, Schiavino D, Gasbarrini A. Irritable Bowel Syndrome and Nickel Allergy: What Is the Role of the Low Nickel Diet? J Neurogastroenterol Motil. 2017 Jan 30;23(1):101-108. doi: 10.5056/jnm16027.

    PubMed 28049864

  • Campanale M, Nucera E, Ojetti V, Cesario V, Di Rienzo TA, D'Angelo G, Pecere S, Barbaro F, Gigante G, De Pasquale T, Rizzi A, Cammarota G, Schiavino D, Franceschi F, Gasbarrini A. Nickel free-diet enhances the Helicobacter pylori eradication rate: a pilot study. Dig Dis Sci. 2014 Aug;59(8):1851-5. doi: 10.1007/s10620-014-3060-3. Epub 2014 Mar 5.

    PubMed 24595654

  • Patriarca G, Schiavino D, Pecora V, Lombardo C, Pollastrini E, Aruanno A, Sabato V, Colagiovanni A, Rizzi A, De Pasquale T, Roncallo C, Decinti M, Musumeci S, Gasbarrini G, Buonomo A, Nucera E. Food allergy and food intolerance: diagnosis and treatment. Intern Emerg Med. 2009 Feb;4(1):11-24. doi: 10.1007/s11739-008-0183-6. Epub 2008 Aug 16.

    PubMed 18709496

  • Veneroni C, Gobbi A, Pompilio PP, Dellaca R, Fasola S, La Grutta S, Leyva A, Porszasz J, Stornelli SR, Fuso L, Valach C, Breyer-Kohansal R, Breyer MK, Hartl S, Contu C, Inchingolo R, Hodgdon K, Kaminsky DA. Reference Equations for Within-Breath Respiratory Oscillometry in White Adults. Respiration. 2024;103(9):521-534. doi: 10.1159/000539532. Epub 2024 Jun 7.

    PubMed 38843786

Questions about this trial

What is this clinical trial studying?

A study testing Collection of environmental, biological, and clinical data in people with Allergic Contact Dermatitis and Metal Allergy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.

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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Angela Rizzi, MD, PhD (+390630154952, angela.rizzi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum concentration of metals (time frame: At enrollment.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06529913, which also lists 9 linked publications.

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 24 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in