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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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Italy
Università di Bologna
NOT_YET_RECRUITING
Bologna
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Roma
Contact Information
Primary
Angela Rizzi, MD, PhD
angela.rizzi@policlinicogemelli.it
+390630154952
Backup
Michele Centrone, MD
michele.centrone@guest.policlinicogemelli.it
+390630154952
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 280
Treatments
Experimental: Allergic contact dermatitis to metals
Patients with allergic contact dermatitis due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
Experimental: Systemic allergic syndromes to metals
Patients with systemic allergic syndrome due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
Experimental: Healthy volunteers
Healthy volunteers without metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators: University of Bologna

This content was sourced from clinicaltrials.gov