Atopic DermatitisUPAD ProjectNCT06996327
The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis of Atopic Dermatitis in Pediatric Age
An observational study of Atopic Dermatitis, run by Federico II University at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Evaluation of dietary consumption of UPFs
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2024to 10 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Caucasian subjects of both sexes, aged ≥6 and ≤10 years, with a diagnosis of atopic dermatitis, and healthy controls matched for age and sex without atopic dermatitis, recruited from the Pediatric Outpatient Clinics of the University Hospital "Federico II".
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, 80131
About this study
Official title: The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis: the UPAD Project
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Evaluation of dietary consumption of UPFs
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of dietary consumption of UPFsOther
Evaluation of dietary consumption of ultraprocessed foods
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with AD | Pediatric patients with a confirmed diagnosis of atopic dermatitis Receives: Other: Evaluation of dietary consumption of UPFs | |
| Healthy controls | healthy controls matched for age and sex without atopic dermatitis Receives: Other: Evaluation of dietary consumption of UPFs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative evaluation of dietary consumption of ultraprocessed foods (UPFs)
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
Measured: First year
Secondary outcomes (5)
Comparative evaluation of dietary consumption of dietary advanced glycation end products (AGEs)
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
Measured: First year
Assessment of skin AGEs accumulation level
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
Measured: First year
Assessment of the effects of AGEs on the expression of tight junction proteins in human keratinocytes
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
Measured: Second year
Effects of AGEs intake on SCORAD/EASI scores
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)
Measured: First year
Evaluation of transepidermal water loss (TEWL)
TEWL assessment
Measured: First year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start10 Jan 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996327
- Sponsor's protocol ID
- 163/2024
- Acronym
- UPAD Project
- Status last verified
- Aug 2026
- First submitted
- 21 May 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis: the UPAD Project
- ClinicalTrials.gov ID
- NCT06996327
- Acronym / sponsor ID
- UPAD Project / 163/2024
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with AD | – | Other: Evaluation of dietary consumption of UPFsPediatric patients with a confirmed diagnosis of atopic dermatitis |
| Healthy controls | – | Other: Evaluation of dietary consumption of UPFshealthy controls matched for age and sex without atopic dermatitis |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Caucasian subjects of both sexes, aged ≥6 and ≤10 years, with a diagnosis of atopic dermatitis, and healthy controls matched for age and sex without atopic dermatitis, recruited from the Pediatric Outpatient Clinics of the University Hospital "Federico II".
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of dietary consumption of UPFsEvaluation of dietary consumption of ultraprocessed foods | Other | Healthy controls, Pediatric patients with AD |
Primary outcome
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
5 secondary outcomes
Comparative evaluation of dietary consumption of dietary advanced glycation end products (AGEs)
Time frame: First year
Assessment of skin AGEs accumulation level
Time frame: First year
Assessment of the effects of AGEs on the expression of tight junction proteins in human keratinocytes
Time frame: Second year
Effects of AGEs intake on SCORAD/EASI scores
Time frame: First year
Evaluation of transepidermal water loss (TEWL)
Time frame: First year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Federico II University at 1 site 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative evaluation of dietary consumption of ultraprocessed foods (UPFs) (time frame: First year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.