VitiligoNCT06731283
Evaluation of Serological Markers of Vitiligo Activity
An observational study of Vitiligo, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The goal of this case-control study is to evaluate the possible applicability of CXCL10, CXCL9, CCL20, and homocysteine as biomarkers of disease activity in vitiligo patients and to compare the levels of these markers with those in healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- How many people
- 85 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Apr 2023to Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Dermatology Department of Hospital de Clínicas de Porto Alegre
Who may be able to join
- Vitiligo
- Older than 18 years
Who cannot join
- Not having diagnosis of vitiligo
- Less than 18 years
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90410-000
About this study
The goal of this case-control study is to evaluate the possible applicability of CXCL10, CXCL9, CCL20, and homocysteine as biomarkers of disease activity in vitiligo patients and to compare the levels of these markers with those in healthy controls.
Read the detailed description
The diagnosis and prognosis assessment in patients with vitiligo are essentially clinical. There are still no validated and established serological markers to objectively assist in defining disease activity. Objective: To evaluate the potential use of the biomarkers CXCL9, CXCL10, CCL20, S100B, and homocysteine to identify disease activity in vitiligo, comparing their values with controls. Methods: A case-control study using previously collected peripheral blood samples from patients aged 18 years or older with a diagnosis of vitiligo and from controls without the disease. The project was approved by the institution's ethics committee. Tests were conducted using ELISA and Luminex kits to measure CXCL9, CXCL10, CCL20, and S100B. For homocysteine, the chemiluminescence method was used.
- Conditions
- Vitiligo
- Keywords
- biomarker, vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo | Patients diagnosed with vitiligo | |
| Controls | Patients that do not have vitiligo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers levels
Assessment of the biomarkers levels in vitiligo group and group control
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start3 Apr 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (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 Hospital de Clinicas de Porto AlegreThe 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tania Cestari, Professor, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731283
- Sponsor's protocol ID
- 2022-0610
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serological Markers of Vitiligo Activity
- ClinicalTrials.gov ID
- NCT06731283
- Acronym / sponsor ID
- 2022-0610
- Conditions
- Vitiligo
- Keywords
- biomarker, vitiligo
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 12 Dec 2024 (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 goal of this case-control study is to evaluate the possible applicability of CXCL10, CXCL9, CCL20, and homocysteine as biomarkers of disease activity in vitiligo patients and to compare the levels of these markers with those in healthy controls.
Detailed description
The diagnosis and prognosis assessment in patients with vitiligo are essentially clinical. There are still no validated and established serological markers to objectively assist in defining disease activity. Objective: To evaluate the potential use of the biomarkers CXCL9, CXCL10, CCL20, S100B, and homocysteine to identify disease activity in vitiligo, comparing their values with controls. Methods: A case-control study using previously collected peripheral blood samples from patients aged 18 years or older with a diagnosis of vitiligo and from controls without the disease. The project was approved by the institution's ethics committee. Tests were conducted using ELISA and Luminex kits to measure CXCL9, CXCL10, CCL20, and S100B. For homocysteine, the chemiluminescence method was used.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitiligo | – | –Patients diagnosed with vitiligo |
| Controls | – | –Patients that do not have vitiligo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Dermatology Department of Hospital de Clínicas de Porto Alegre
Key inclusion criteria (2 listed)
- Vitiligo
- Older than 18 years
Key exclusion criteria (2 listed)
- Not having diagnosis of vitiligo
- Less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarkers levels
Time frame: through study completion, an average of 2 year
Assessment of the biomarkers levels in vitiligo group and group control
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 12 Dec 2024.
- 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. This study is not recruiting at the moment.
Tania Cestari, Professor principal investigator
Hospital de Clinicas de Porto Alegre
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 Vitiligo, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2024. 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 Brazil. 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?
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?
Biomarkers levels (time frame: through study completion, an average of 2 year). 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 12 Dec 2024.