VitiligoNCT05121532
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo
A study testing Interleukin-15 and Interleukin-22 in people with Vitiligo, run by Sohag University.
Trial summary
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients with Non-segmental Vitiligo before and after phototherapy Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Interleukin-15 and Interleukin-22
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Patients suffering from non segmental vitiligo.
- Patients not on medical treatment or phototherapy for vitiligo in the last 3 months.
Who cannot join
- • Patients with systemic or cutaneous inflammatory disorders.
- Patients on treatment for vitiligo in last 3 months.
- Pregnant and lactating patients.
- Patients with history of diabetes.
- Patients with history of autoimmune diseases.
About this study
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients with Non-segmental Vitiligo before and after phototherapy
Read the detailed description
This prospective study will include 30 patients with NSV, attending the Outpatient Clinics of Dermatology at Sohag University Hospitals, as well as 30 normal volunteers as control.
This study will be submitted for approval by Research and Ethical committees at Sohag Faculty of Medicine. An informed written consent will be obtained from each subject prior to participation in the study after full explanation of the procedure.
- Conditions
- Vitiligo
- Being tested
- Interleukin-15 and Interleukin-22
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-15 and Interleukin-22Diagnostic test
Serum Interleukin-15 and Interleukin-22 in non segmental vitiligo
| Study group | Role | What they receive |
|---|---|---|
| non segmental vitiligo | Active comparator | serum analysis Receives: Diagnostic Test: Interleukin-15 and Interleukin-22 |
| normal volunteer | Active comparator | serum analysis Receives: Diagnostic Test: Interleukin-15 and Interleukin-22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels
3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate
- Serum IL15 level .
- Serum IL22 level. 3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate
- Serum IL15 level . 2. Serum IL22 level.
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 posted16 Nov 2021
- Study startJan 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Saeed Badrous, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121532
- Sponsor's protocol ID
- Soh-Med-21-11-12
- Status last verified
- Nov 2021
- First submitted
- 14 Nov 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo
- ClinicalTrials.gov ID
- NCT05121532
- Acronym / sponsor ID
- Soh-Med-21-11-12
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Nov 2021 (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.
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients with Non-segmental Vitiligo before and after phototherapy
Detailed description
This prospective study will include 30 patients with NSV, attending the Outpatient Clinics of Dermatology at Sohag University Hospitals, as well as 30 normal volunteers as control.
This study will be submitted for approval by Research and Ethical committees at Sohag Faculty of Medicine. An informed written consent will be obtained from each subject prior to participation in the study after full explanation of the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non segmental vitiligo | Active comparator | Diagnostic Test: Interleukin-15 and Interleukin-22serum analysis |
| normal volunteer | Active comparator | Diagnostic Test: Interleukin-15 and Interleukin-22serum analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Patients suffering from non segmental vitiligo.
Key exclusion criteria (5 listed)
- • Patients with systemic or cutaneous inflammatory disorders.
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 |
|---|---|---|
| Interleukin-15 and Interleukin-22Serum Interleukin-15 and Interleukin-22 in non segmental vitiligo | Diagnostic test | non segmental vitiligo, normal volunteer |
Primary outcome
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels
Time frame: 3 months
3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate 1. Serum IL15 level . 2. Serum IL22 level. 3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate 1. Serum IL15 level . 2. Serum IL22 level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Interleukin-15 and Interleukin-22 in people with Vitiligo, run by Sohag 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 2 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 16 Nov 2021. 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?
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels (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 16 Nov 2021.