An interventional study of Collection of environmental, biological, and clinical data in Allergic Contact Dermatitis, Metal Allergy and Food Allergy, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
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).
Participants will undergo:
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).
52 studies on the registry are indexed under Dermatitis, Allergic Contact; 11 are open to participants now.
This study's planned enrollment of 280 is above the median of 45 across 41 interventional studies indexed under Dermatitis, Allergic Contact.
Browse Dermatitis, Allergic Contact studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with allergic contact dermatitis due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
Diagnostic Test: Collection of environmental, biological, and clinical data
Patients with systemic allergic syndrome due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
Diagnostic Test: Collection of environmental, biological, and clinical data
Healthy volunteers without metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
Diagnostic Test: Collection of environmental, biological, and clinical data
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.
Serum concentration of metals
Measurement of serum concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.
Time frame: At enrollment.
Urinary concentration of metals
Measurement of urinary concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.
Time frame: At enrollment.
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.
Time frame: At enrollment.
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.
Time frame: At enrollment.
Serum concentration of zonulin
Measurement of serum zonulin.
Time frame: At enrollment.
Serum concentration of protein oxidation products
Measurement of serum protein oxidation products as markers of systemic oxidative stress.
Time frame: At enrollment.
Plan to share: 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".
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