Inflammatory Skin DiseaseEPICANCT07708896
Evolution of Chronic Inflammatory Skin Diseases
An observational study of Inflammatory Skin Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
monocentric retrospective-prospective observational study evaluating the clinical evolution of common chronic inflammatory skin diseases, including atopic dermatitis, psoriasis, prurigo nodularis, chronic hand eczema, and hidradenitis suppurativa. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Inflammatory Skin Disease
- What is being tested?
- advanced sistemic therapies
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2026to Jul 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: patients affected with inflammatory skin conditions including atopic dermatitis, prurigo nodularis, Hidradenitis suppurativa, psoriasis
Who may be able to join
- Age ≥12 years.
- Patients with a confirmed clinical diagnosis of atopic dermatitis (AD), prurigo nodularis (PN), psoriasis (PSO), chronic hand eczema (CHE), or hidradenitis suppurativa (HS) attending the dermatology outpatient clinics of Fondazione Policlinico Universitario A. Gemelli IRCCS.
- Availability of clinical data at baseline and at subsequent follow-up visits performed according to routine clinical practice.
Who cannot join
- Age <12 years; absence of the minimum required data (treatment start date and at least one follow-up visit with a clinical score).
- Refusal or inability to understand and sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Agostino Gemelli IRCCS
Rome, 00168
Ketty Peris, Prof
About this study
monocentric retrospective-prospective observational study evaluating the clinical evolution of common chronic inflammatory skin diseases, including atopic dermatitis, psoriasis, prurigo nodularis, chronic hand eczema, and hidradenitis suppurativa. The study will collect demographic, clinical, therapeutic, and validated clinimetric data from patients aged ≥12 years. Its primary aim is to describe changes in disease severity over time. Secondary objectives include identifying demographic, clinical, and treatment-related predictors of moderate-to-severe disease and unfavorable outcomes. Data will cover a 7-year retrospective period and a 10-year prospective follow-up.
- Conditions
- Inflammatory Skin Disease
- Being tested
- advanced sistemic therapies
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
advanced sistemic therapiesDrug
evaluate the safety and efficacy of advanced sistemic therapies used in inflammatory skin diseases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Over Time in Eczema Area and Severity Index (EASI)
Change over time in Eczema Area and Severity Index (EASI) in participants with atopic dermatitis. EASI ranges from 0 to 72, with higher scores indicating greater disease severity.
Measured: Baseline and every 16 ± 4 weeks, up to 120 months
Change Over Time in SCORing Atopic Dermatitis (SCORAD)
Change over time in SCORing Atopic Dermatitis (SCORAD) in participants with atopic dermatitis. SCORAD ranges from 0 to 103, with higher scores indicating greater disease severity.
Measured: Baseline and every 16 ± 4 weeks, up to 120 months
Change Over Time in Patient-Oriented Eczema Measure (POEM)
Change over time in Patient-Oriented Eczema Measure (POEM) in participants with atopic dermatitis. POEM ranges from 0 to 28, with higher scores indicating greater patient-reported disease severity.
Measured: Baseline and every 16 ± 4 weeks, up to 120 months
Change Over Time in Psoriasis Area and Severity Index (PASI)
Change over time in Psoriasis Area and Severity Index (PASI) in participants with psoriasis. PASI ranges from 0 to 72, with higher scores indicating greater disease severity.
Measured: Baseline and every 16 ± 4 weeks, up to 120 months
Change Over Time in Hand Eczema Severity Index (HECSI)
Change over time in Hand Eczema Severity Index (HECSI) in participants with chronic hand eczema. HECSI ranges from 0 to 360, with higher scores indicating greater disease severity.
Measured: Baseline and every 16 ± 4 weeks, up to 120 months
Change Over Time in Investigator's Global Assessment for Prurigo Nodularis
Change in Investigator Global Assessment (IGA) in patients with prurigo nodularis
Measured: Baseline and every 16 ± 4 weeks, up to 120 months
Change Over Time in Itch Numerical Rating Scale (NRS)
Change over time in itch intensity assessed using the Numerical Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch. Higher scores indicate worse itch.
Measured: baseline and every 16 ± 4 weeks, up to 120 months
Change Over Time in Sleep Numerical Rating Scale (NRS)
Change over time in sleep disturbance assessed using the Numerical Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater sleep disturbance.
Measured: baseline and every 16 ± 4 weeks, up to 120 months
Change Over Time in Dermatology Life Quality Index (DLQI)
Change over time in Dermatology Life Quality Index (DLQI). Scores range from 0 to 30, with higher scores indicating greater impairment in dermatology-related quality of life.
Measured: baseline and every 16 ± 4 weeks, up to 120 months
Change Over Time in Hurley Stage
Change over time in hidradenitis suppurativa severity according to Hurley staging. Hurley stage ranges from Stage I to Stage III, with higher stages indicating more severe disease.
Measured: baseline and every 16 ± 4 weeks, up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jul 2026
- Primary completionJul 2030 (estimated)
- Study completionJul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Skin DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketty Peris, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708896
- Sponsor's protocol ID
- 27085
- Acronym
- EPICA
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Chronic Inflammatory Skin Diseases
- ClinicalTrials.gov ID
- NCT07708896
- Acronym / sponsor ID
- EPICA / 27085
- Conditions
- Inflammatory Skin Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2036 (estimated)
- First posted
- 16 Jul 2026 (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.
monocentric retrospective-prospective observational study evaluating the clinical evolution of common chronic inflammatory skin diseases, including atopic dermatitis, psoriasis, prurigo nodularis, chronic hand eczema, and hidradenitis suppurativa. The study will collect demographic, clinical, therapeutic, and validated clinimetric data from patients aged ≥12 years. Its primary aim is to describe changes in disease severity over time. Secondary objectives include identifying demographic, clinical, and treatment-related predictors of moderate-to-severe disease and unfavorable outcomes. Data will cover a 7-year retrospective period and a 10-year prospective follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients affected with inflammatory skin conditions including atopic dermatitis, prurigo nodularis, Hidradenitis suppurativa, psoriasis
Key inclusion criteria (3 listed)
- Age ≥12 years.
- Patients with a confirmed clinical diagnosis of atopic dermatitis (AD), prurigo nodularis (PN), psoriasis (PSO), chronic hand eczema (CHE), or hidradenitis suppurativa (HS) attending the dermatology outpatient clinics of Fondazione Policlinico Universitario A. Gemelli IRCCS.
- Availability of clinical data at baseline and at subsequent follow-up visits performed according to routine clinical practice.
Key exclusion criteria (2 listed)
- Age <12 years; absence of the minimum required data (treatment start date and at least one follow-up visit with a clinical score).
- Refusal or inability to understand and sign the informed consent form.
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 |
|---|---|---|
| advanced sistemic therapiesevaluate the safety and efficacy of advanced sistemic therapies used in inflammatory skin diseases. | Drug | – |
Primary outcome
Change Over Time in Eczema Area and Severity Index (EASI)
Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
Change over time in Eczema Area and Severity Index (EASI) in participants with atopic dermatitis. EASI ranges from 0 to 72, with higher scores indicating greater disease severity.
Change Over Time in SCORing Atopic Dermatitis (SCORAD)
Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
Change over time in SCORing Atopic Dermatitis (SCORAD) in participants with atopic dermatitis. SCORAD ranges from 0 to 103, with higher scores indicating greater disease severity.
Change Over Time in Patient-Oriented Eczema Measure (POEM)
Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
Change over time in Patient-Oriented Eczema Measure (POEM) in participants with atopic dermatitis. POEM ranges from 0 to 28, with higher scores indicating greater patient-reported disease severity.
Change Over Time in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
Change over time in Psoriasis Area and Severity Index (PASI) in participants with psoriasis. PASI ranges from 0 to 72, with higher scores indicating greater disease severity.
Change Over Time in Hand Eczema Severity Index (HECSI)
Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
Change over time in Hand Eczema Severity Index (HECSI) in participants with chronic hand eczema. HECSI ranges from 0 to 360, with higher scores indicating greater disease severity.
Change Over Time in Investigator's Global Assessment for Prurigo Nodularis
Time frame: Baseline and every 16 ± 4 weeks, up to 120 months
Change in Investigator Global Assessment (IGA) in patients with prurigo nodularis
Change Over Time in Itch Numerical Rating Scale (NRS)
Time frame: baseline and every 16 ± 4 weeks, up to 120 months
Change over time in itch intensity assessed using the Numerical Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch. Higher scores indicate worse itch.
Change Over Time in Sleep Numerical Rating Scale (NRS)
Time frame: baseline and every 16 ± 4 weeks, up to 120 months
Change over time in sleep disturbance assessed using the Numerical Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater sleep disturbance.
Change Over Time in Dermatology Life Quality Index (DLQI)
Time frame: baseline and every 16 ± 4 weeks, up to 120 months
Change over time in Dermatology Life Quality Index (DLQI). Scores range from 0 to 30, with higher scores indicating greater impairment in dermatology-related quality of life.
Change Over Time in Hurley Stage
Time frame: baseline and every 16 ± 4 weeks, up to 120 months
Change over time in hidradenitis suppurativa severity according to Hurley staging. Hurley stage ranges from Stage I to Stage III, with higher stages indicating more severe disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Ketty Peris principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Inflammatory Skin Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ketty Peris (+390630155701, ketty.peris@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Over Time in Eczema Area and Severity Index (EASI) (time frame: Baseline and every 16 ± 4 weeks, up to 120 months). The study lists 10 primary outcomes in all. 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 25 Sep 2026.