Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06996327

The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis of Atopic Dermatitis in Pediatric Age

Atopic dermatitis (AD) is a common chronic inflammatory skin condition, primarily affecting children in urban and high-income areas. Its prevalence has increased significantly over the past 30 years, with up to 20% of children affected, often within their first year of life. AD is characterized by erythematous, scaly, pruritic lesions, xerosis, and frequent atopy, with distinct clinical features in children compared to adults.

The pathophysiology of AD involves skin barrier dysfunction, immune response alterations, and environmental triggers. Genetic factors, particularly mutations in the filaggrin gene, play a significant role in severe AD, leading to increased water loss and skin dehydration. Immunologically, a Th2-predominant response drives inflammation, and environmental exposures, such as air pollutants and irritants, exacerbate the condition.

Recent studies suggest that dietary habits, particularly a high intake of ultra-processed foods (UPFs), may contribute to AD by activating inflammatory pathways. UPFs, rich in advanced glycation end products (AGEs), induce oxidative stress and inflammation, potentially worsening skin damage. This study aims to explore the potential role of UPF-derived compounds, especially AGEs, in the pathogenesis of pediatric AD.

Recruiting

Interested in participating?

Request Info

Key information

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location status: Recruiting

Location contact

Roberto Berni Canani, MD, PhD

CONTACT

[email protected]

0817462680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caucasian subjects, both sexes, age: ≥6 months and ≤10 years, with a confirmed diagnosis of atopic dermatitis, and healthy controls matched for age and sex without atopic dermatitis;
  • Written informed consent obtained from the participants and/or their parents/legal guardians.

Exclusion criteria

  • Non-Caucasian ethnicity; age < 6 or > 10 years
  • Presence of other chronic conditions: hypereosinophilic syndrome, fungal or viral infections, connective tissue disorders, autoimmune diseases, vasculitis, bullous dermatoses (e.g., pemphigus), drug hypersensitivity reactions, graft-versus-host disease, monogenic disorders (e.g., Marfan syndrome type 2, Hyper-IgE syndrome)
  • Presence of scars, nevi, or unusual skin lesions on both forearms
  • Absence of written informed consent

Treatment and study plan

Evaluation of dietary consumption of UPFs

Other

Evaluation of dietary consumption of ultraprocessed foods

Primary outcomes

  1. Comparative evaluation of dietary consumption of ultraprocessed foods (UPFs)

    Time frame: First year

    Comparative evaluation of dietary consumption of UPFs in patients aged from 6 months to 10 years diagnosed with AD and in healthy controls matched for age and sex

Secondary outcomes

  1. Comparative evaluation of dietary consumption of dietary advanced glycation end products (AGEs)

    Time frame: First year

    Comparative evaluation of dietary consumption of dietary AGEs in patients aged from 6 months to 10 years diagnosed with AD and in healthy controls matched for age and sex

  2. Assessment of skin AGEs accumulation level

    Time frame: First year

    Evaluation of subcutaneous AGEs concentrations in patients aged from 6 months to 10 years diagnosed with AD and in healthy controls matched for age and sex

  3. Assessment of the effects of AGEs on the expression of tight junction proteins in human keratinocytes

    Time frame: Second year

    Assessment of the effects of AGEs on the expression of tight junction proteins in human keratinocytes, both under basal conditions and after in vitro stimulation with AGEs

  4. Effects of AGEs intake on SCORAD/EASI scores

    Time frame: First year

    Correlation between AGEs intake and Scoring Atopic Dermatitis (SCORAD Score 0 absent - 130 severe) and Eczema Area and Severity Index (EASI Score 0 absent - 72 severe)

  5. Evaluation of transepidermal water loss (TEWL)

    Time frame: First year

    TEWL assessment

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis: the UPAD Project

Acronym: UPAD Project

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 30, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.