NCT06529913 Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases
| NCT ID | NCT06529913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Allergic Contact Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2025-01-13 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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: * 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).
Eligibility 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.
Contact & Investigator
Angela Rizzi, MD, PhD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06529913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Allergic Contact Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06529913 currently recruiting?
Yes, NCT06529913 is actively recruiting participants. Contact the research team at angela.rizzi@policlinicogemelli.it for enrollment information.
Where is the NCT06529913 trial being conducted?
This trial is being conducted at Bologna, Italy, Roma, Italy.
Who is sponsoring the NCT06529913 clinical trial?
NCT06529913 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Angela Rizzi, MD, PhD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 280 participants.