IL35, VitiligoNCT05980390
IL35 Level in Vitiligo
An observational study of IL35, Vitiligo, run by Cairo University.
Trial summary
The aim of this observational study is to evaluate the level of the IL-35 protein in tissue biopsy from patients with active \& stable vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- IL35, Vitiligo
- What is being tested?
- IL 35 in tissue biopsy
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2023to 30 Oct 2023
- 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 to 60 years
- All sexes
- Adult
Study population: Patients with active and stable vitiligo together with normal subjects
Who may be able to join
- Patients with active and stable vitiligo
Who cannot join
- Pregnant and lactating women.
- Patients with associated autoimmune or other dermatological diseases e.g., Alopecia areata and lupus erythematous.
- Patients already on both topical and systemic treatment at the time of recruitment.
- Patients on Immunosuppressive drugs.
- Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post inflammatory hypopigmentation and leprosy as excluded by lack of accentuation by wood's light examination.
About this study
Official title: Assessment of Tissue Levels of IL-35 in Active and Stable Vitiligo
The aim of this observational study is to evaluate the level of the IL-35 protein in tissue biopsy from patients with active \& stable vitiligo.
- Conditions
- IL35, Vitiligo
- Being tested
- IL 35 in tissue biopsy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL 35 in tissue biopsyDiagnostic test
Elisa testing
| Study group | Role | What they receive |
|---|---|---|
| Active vitiligo | Not described Receives: Diagnostic Test: IL 35 in tissue biopsy | |
| Stable vitiligo | Not described Receives: Diagnostic Test: IL 35 in tissue biopsy | |
| Normal controls | Not described Receives: Diagnostic Test: IL 35 in tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of IL35 in tissue biopsy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start10 Aug 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IL35, VitiligoStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980390
- Sponsor's protocol ID
- IL35 in vitiligo
- Status last verified
- Jul 2023
- First submitted
- 29 Jul 2023
- Last updated
- 8 Aug 2023
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tissue Levels of IL-35 in Active and Stable Vitiligo
- ClinicalTrials.gov ID
- NCT05980390
- Acronym / sponsor ID
- IL35 in vitiligo
- Conditions
- IL35, Vitiligo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 8 Aug 2023 (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.
The aim of this observational study is to evaluate the level of the IL-35 protein in tissue biopsy from patients with active \& stable vitiligo.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active vitiligo | – | Diagnostic Test: IL 35 in tissue biopsy |
| Stable vitiligo | – | Diagnostic Test: IL 35 in tissue biopsy |
| Normal controls | – | Diagnostic Test: IL 35 in tissue biopsy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with active and stable vitiligo together with normal subjects
Key inclusion criteria (1 listed)
- Patients with active and stable vitiligo
Key exclusion criteria (5 listed)
- Pregnant and lactating women.
- Patients with associated autoimmune or other dermatological diseases e.g., Alopecia areata and lupus erythematous.
- Patients already on both topical and systemic treatment at the time of recruitment.
- Patients on Immunosuppressive drugs.
- Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post inflammatory hypopigmentation and leprosy as excluded by lack of accentuation by wood's light examination.
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 |
|---|---|---|
| IL 35 in tissue biopsyElisa testing | Diagnostic test | Active vitiligo, Normal controls, Stable vitiligo |
Primary outcome
level of IL35 in tissue biopsy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of IL35, Vitiligo, run by Cairo University.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
level of IL35 in tissue biopsy (time frame: 3 months). 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 8 Aug 2023.