VitiligoNCT05569096
Tregs CD25 CXCL9 in Vitiligo
An observational study of Vitiligo and CD25 Deficiency, run by Assiut University.
Trial summary
Clinical significance of circulating T regulatory cells , soluble CD25 and CXCL9 to assess disease activity of vitiligo. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Vitiligo, CD25 Deficiency, Chemokine (C-X-C Motif)
- What is being tested?
- ELIZA , Flowcytometry
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to 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 15 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: This study include 50 patients with clinically diagnosed vitiligo. Eligible patients are those attending the dermatology, venereology, and andrology outpatient clinic at Assiut University Hospital. Separately, the control group included 40 healthy subjects who were matched to vitiligo patients according to age and sex.
Who may be able to join
None listed.
Who cannot join
- The following patients were excluded from this study:
- Patients receiving systemic treatment in the last two months.
- Patients with any autoimmune disease, such as rheumatoid arthritis. inflammatory bowel disease, psoriasis, or systemic lupus erythematosus; patients with type 1 diabetes mellitus.
- Patients with any thyroid and/or neoplastic diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Significance of Circulating T Regulatory Cells , Soluble CD25 and CXCL9 to Assess Disease Activity of Vitiligo.
Clinical significance of circulating T regulatory cells , soluble CD25 and CXCL9 to assess disease activity of vitiligo.
Read the detailed description
Vitiligo is an acquired and polygenic skin depigmenting disease characterized by bilateral, symmetrical depigmented patches over the entire body.
Its pathogenesis is multifactorial; however, the exact mechanisms that integrate the individual genetic susceptibility, melanocyte auto aggression, and failure of immune tolerance mechanisms are still not fully understood. The presence of these autoreactive CD8+ and CD4+ T cells in vitiligo patients' skin and blood samples . indicates a dysregulation of regulatory T-cell mechanism, which can suppress these cells.
Previous studies have reported an altered Treg cell frequency and function in vitiligo patients.
FoxP3 is the key transcriptional regulators of Tregs which mediate Treg cell function by repressing the expression of cytokines (IL2 and IL4 ) and upregulate the Treg cell markers (CTLA-4 and CD25 ).
Expression of IL-2 and its receptor CD25 are the most fundamental events in the host immune response. Thus any disorder in which T lymphocyte activation occurs at a substantial level is expected to induce expression of CD25 beyond ambient levels; this had been reported in atopic asthma, multiple sclerosis, allergic responses.
CD4+ CD25 FoxP3+ Tregs are important in maintaining self-tolerance and regulating immune responses in both physiological and pathological conditions .
Chemokines are important inflammatory factors that participate in many autoimmune responses.
C-X-C motif chemokine ligand 9 (CXCL9) is linked to the Th1 pattern and has been suggested as one of the most relevant chemokine axes that promote T-cell migration in different autoimmune and inflammatory processes.
In vitiligo, CXCL9 has been suggested to promote melanocyte-specic CTLs to in ltrate into the basal layer of the epidermis to attack melanocytes, resulting in the deficiency of melanin.
- Conditions
- Vitiligo, CD25 Deficiency, Chemokine (C-X-C Motif), Tregs
- Being tested
- ELIZA , Flowcytometry
- Medical subject headings
- Vitiligo, Interleukin 2 Receptor, Alpha, Deficiency of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELIZA , FlowcytometryDiagnostic test
CD25 , CXCL9 by ELISA. T cell population , T regulatory cells by Flow cytometry.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess role of circulating T regulatory cells, soluble CD25 and CXCL9 in disease activity of vitiligo
compare presences of T regulatory cells , soluble CD25 and CXCL9 between healthy control and vitiligo patients.
To assess role of circulating T regulatory cells, soluble CD25 and CXCL9 in disease activity of vitiligo
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Hashim Mohammed , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569096
- Sponsor's protocol ID
- Tregs CD25 CXCL9 vitiligo
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gharib K, Gadallah H, Elsayed A. Chemokines in Vitiligo Pathogenesis: CXCL10 and 12. J Clin Aesthet Dermatol. 2021 Sep;14(9):27-32.
PubMed 34980968Marchioro HZ, Silva de Castro CC, Fava VM, Sakiyama PH, Dellatorre G, Miot HA. Update on the pathogenesis of vitiligo. An Bras Dermatol. 2022 Jul-Aug;97(4):478-490. doi: 10.1016/j.abd.2021.09.008. Epub 2022 May 25.
PubMed 35643735Bergqvist C, Ezzedine K. Vitiligo: A Review. Dermatology. 2020;236(6):571-592. doi: 10.1159/000506103. Epub 2020 Mar 10.
PubMed 32155629Giri PS, Dwivedi M, Laddha NC, Begum R, Bharti AH. Altered expression of nuclear factor of activated T cells, forkhead box P3, and immune-suppressive genes in regulatory T cells of generalized vitiligo patients. Pigment Cell Melanoma Res. 2020 Jul;33(4):566-578. doi: 10.1111/pcmr.12862. Epub 2020 Jan 23.
PubMed 31917889Yang L, Yang S, Lei J, Hu W, Chen R, Lin F, Xu AE. Role of chemokines and the corresponding receptors in vitiligo: A pilot study. J Dermatol. 2018 Jan;45(1):31-38. doi: 10.1111/1346-8138.14004. Epub 2017 Nov 8.
PubMed 29115683Yang L, Wei Y, Sun Y, Shi W, Yang J, Zhu L, Li M. Interferon-gamma Inhibits Melanogenesis and Induces Apoptosis in Melanocytes: A Pivotal Role of CD8+ Cytotoxic T Lymphocytes in Vitiligo. Acta Derm Venereol. 2015 Jul;95(6):664-70. doi: 10.2340/00015555-2080.
PubMed 25721262
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Circulating T Regulatory Cells , Soluble CD25 and CXCL9 to Assess Disease Activity of Vitiligo.
- ClinicalTrials.gov ID
- NCT05569096
- Acronym / sponsor ID
- Tregs CD25 CXCL9 vitiligo
- Conditions
- Vitiligo, CD25 Deficiency, Chemokine (C-X-C Motif), Tregs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 6 Oct 2022 (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.
Clinical significance of circulating T regulatory cells , soluble CD25 and CXCL9 to assess disease activity of vitiligo.
Detailed description
Vitiligo is an acquired and polygenic skin depigmenting disease characterized by bilateral, symmetrical depigmented patches over the entire body.
Its pathogenesis is multifactorial; however, the exact mechanisms that integrate the individual genetic susceptibility, melanocyte auto aggression, and failure of immune tolerance mechanisms are still not fully understood. The presence of these autoreactive CD8+ and CD4+ T cells in vitiligo patients' skin and blood samples . indicates a dysregulation of regulatory T-cell mechanism, which can suppress these cells.
Previous studies have reported an altered Treg cell frequency and function in vitiligo patients.
FoxP3 is the key transcriptional regulators of Tregs which mediate Treg cell function by repressing the expression of cytokines (IL2 and IL4 ) and upregulate the Treg cell markers (CTLA-4 and CD25 ).
Expression of IL-2 and its receptor CD25 are the most fundamental events in the host immune response. Thus any disorder in which T lymphocyte activation occurs at a substantial level is expected to induce expression of CD25 beyond ambient levels; this had been reported in atopic asthma, multiple sclerosis, allergic responses.
CD4+ CD25 FoxP3+ Tregs are important in maintaining self-tolerance and regulating immune responses in both physiological and pathological conditions .
Chemokines are important inflammatory factors that participate in many autoimmune responses.
C-X-C motif chemokine ligand 9 (CXCL9) is linked to the Th1 pattern and has been suggested as one of the most relevant chemokine axes that promote T-cell migration in different autoimmune and inflammatory processes.
In vitiligo, CXCL9 has been suggested to promote melanocyte-specic CTLs to in ltrate into the basal layer of the epidermis to attack melanocytes, resulting in the deficiency of melanin.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This study include 50 patients with clinically diagnosed vitiligo. Eligible patients are those attending the dermatology, venereology, and andrology outpatient clinic at Assiut University Hospital. Separately, the control group included 40 healthy subjects who were matched to vitiligo patients according to age and sex.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients receiving systemic treatment in the last two months.
- Patients with any autoimmune disease, such as rheumatoid arthritis. inflammatory bowel disease, psoriasis, or systemic lupus erythematosus; patients with type 1 diabetes mellitus.
- Patients with any thyroid and/or neoplastic diseases.
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 |
|---|---|---|
| ELIZA , FlowcytometryCD25 , CXCL9 by ELISA. T cell population , T regulatory cells by Flow cytometry. | Diagnostic test | – |
Primary outcome
To assess role of circulating T regulatory cells, soluble CD25 and CXCL9 in disease activity of vitiligo
Time frame: Baseline
compare presences of T regulatory cells , soluble CD25 and CXCL9 between healthy control and vitiligo patients. To assess role of circulating T regulatory cells, soluble CD25 and CXCL9 in disease activity of vitiligo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Background: PubMed 34980968Gharib K, Gadallah H, Elsayed A. Chemokines in Vitiligo Pathogenesis: CXCL10 and 12. J Clin Aesthet Dermatol. 2021 Sep;14(9):27-32.
- Background: PubMed 35643735Marchioro HZ, Silva de Castro CC, Fava VM, Sakiyama PH, Dellatorre G, Miot HA. Update on the pathogenesis of vitiligo. An Bras Dermatol. 2022 Jul-Aug;97(4):478-490. doi: 10.1016/j.abd.2021.09.008. Epub 2022 May 25.
- Background: PubMed 32155629Bergqvist C, Ezzedine K. Vitiligo: A Review. Dermatology. 2020;236(6):571-592. doi: 10.1159/000506103. Epub 2020 Mar 10.
- Background: PubMed 31917889Giri PS, Dwivedi M, Laddha NC, Begum R, Bharti AH. Altered expression of nuclear factor of activated T cells, forkhead box P3, and immune-suppressive genes in regulatory T cells of generalized vitiligo patients. Pigment Cell Melanoma Res. 2020 Jul;33(4):566-578. doi: 10.1111/pcmr.12862. Epub 2020 Jan 23.
- Background: PubMed 29115683Yang L, Yang S, Lei J, Hu W, Chen R, Lin F, Xu AE. Role of chemokines and the corresponding receptors in vitiligo: A pilot study. J Dermatol. 2018 Jan;45(1):31-38. doi: 10.1111/1346-8138.14004. Epub 2017 Nov 8.
- Background: PubMed 25721262Yang L, Wei Y, Sun Y, Shi W, Yang J, Zhu L, Li M. Interferon-gamma Inhibits Melanogenesis and Induces Apoptosis in Melanocytes: A Pivotal Role of CD8+ Cytotoxic T Lymphocytes in Vitiligo. Acta Derm Venereol. 2015 Jul;95(6):664-70. doi: 10.2340/00015555-2080.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo and CD25 Deficiency, run by Assiut 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 0 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: status not confirmed, as of the sponsor's last update on 6 Oct 2022. 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?
Contact jian hashim, Assistant lecturer (01061545086, jian_hashim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess role of circulating T regulatory cells, soluble CD25 and CXCL9 in disease activity of vitiligo (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05569096, which also lists 6 linked publications.
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 6 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.