Interleukin-6NCT07001904
Interleukin-6 in Plaque Psoriasis and Its Possible Role in Disease Severity
An observational study of Interleukin-6 and Plaque Psoriasis, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to evaluate serum IL-6 levels in plaque psoriasis patients and investigate their correlation with disease severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interleukin-6, Plaque Psoriasis, Disease Severity
- What is being tested?
- Enzyme-linked immunosorbent assay (ELISA)
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 31 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This cross-sectional work had been performed on 30 individuals with plaque psoriasis and 20 sex- and age-matched healthy controls.
Who may be able to join
- Age above 18 years.
- Both sexes.
- Patients clinically diagnosed with plaque psoriasis.
Who cannot join
- Patients who had received any treatment for psoriasis in the last three months.
- Patients with other types of psoriasis.
- Those currently receiving systemic treatment.
- Individuals with other inflammatory diseases.
- Pregnant or lactating women.
- Those using contraceptive pills.
- Patients with metabolic conditions like diabetes mellitus or thyroid disorders.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate serum IL-6 levels in plaque psoriasis patients and investigate their correlation with disease severity.
Read the detailed description
Psoriasis is a chronic, immune-mediated inflammatory dermatological condition that impacts around 0.2% to 4.8% of the worldwide population.
Interleukin (IL)-6 is a pleiotropic cytokine that regulates immunity, hematopoiesis, and inflammation. It is produced by keratinocytes, endothelial cells, fibroblasts, and immune cells like macrophages and dendritic cells. Increased IL-6 expression has been observed in psoriatic lesions, suggesting its involvement in disease pathogenesis
- Conditions
- Interleukin-6, Plaque Psoriasis, Disease Severity
- Being tested
- Enzyme-linked immunosorbent assay (ELISA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme-linked immunosorbent assay (ELISA)Other
The enzyme-linked immunosorbent assay (ELISA) was utilized in order to determine the levels of IL-6 in the serum
| Study group | Role | What they receive |
|---|---|---|
| Patients group | Patients with plaque psoriasis. Receives: Other: Enzyme-linked immunosorbent assay (ELISA) | |
| Control group | Sex- and age-matched healthy control individuals. Receives: Other: Enzyme-linked immunosorbent assay (ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity
Disease severity was assessed using the Psoriasis Area and Severity Index (PASI), categorizing patients into mild (PASI <5), moderate (PASI 5-10), and severe (PASI >10) groups.
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Nov 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interleukin-6Studies of the same condition, open and under way.
- More trials run by Tanta 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Jamal Khaled Jadallah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001904
- Sponsor's protocol ID
- 36264MS308/9/23
- Status last verified
- May 2025
- First submitted
- 24 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-6 in Plaque Psoriasis and Its Possible Role in Disease Severity
- ClinicalTrials.gov ID
- NCT07001904
- Acronym / sponsor ID
- 36264MS308/9/23
- Conditions
- Interleukin-6, Plaque Psoriasis, Disease Severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 3 Jun 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.
This study aimed to evaluate serum IL-6 levels in plaque psoriasis patients and investigate their correlation with disease severity.
Detailed description
Psoriasis is a chronic, immune-mediated inflammatory dermatological condition that impacts around 0.2% to 4.8% of the worldwide population.
Interleukin (IL)-6 is a pleiotropic cytokine that regulates immunity, hematopoiesis, and inflammation. It is produced by keratinocytes, endothelial cells, fibroblasts, and immune cells like macrophages and dendritic cells. Increased IL-6 expression has been observed in psoriatic lesions, suggesting its involvement in disease pathogenesis
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Other: Enzyme-linked immunosorbent assay (ELISA)Patients with plaque psoriasis. |
| Control group | – | Other: Enzyme-linked immunosorbent assay (ELISA)Sex- and age-matched healthy control individuals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional work had been performed on 30 individuals with plaque psoriasis and 20 sex- and age-matched healthy controls.
Key inclusion criteria (3 listed)
- Age above 18 years.
- Both sexes.
- Patients clinically diagnosed with plaque psoriasis.
Key exclusion criteria (7 listed)
- Patients who had received any treatment for psoriasis in the last three months.
- Patients with other types of psoriasis.
- Those currently receiving systemic treatment.
- Individuals with other inflammatory diseases.
- Pregnant or lactating women.
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 |
|---|---|---|
| Enzyme-linked immunosorbent assay (ELISA)The enzyme-linked immunosorbent assay (ELISA) was utilized in order to determine the levels of IL-6 in the serum | Other | Control group, Patients group |
Primary outcome
Disease severity
Time frame: 3 months post-procedure
Disease severity was assessed using the Psoriasis Area and Severity Index (PASI), categorizing patients into mild (PASI <5), moderate (PASI 5-10), and severe (PASI >10) groups.
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 3 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Interleukin-6 and Plaque Psoriasis, run by Tanta University at 1 site in Egypt.
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 7 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 3 Jun 2025. 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 Egypt. 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?
Disease severity (time frame: 3 months post-procedure). 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 3 Jun 2025.