VITILIGONCT03249064
Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo
An observational study of VITILIGO, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
This study aims to evaluate some differences in the immune system between patients with vitiligo and patients without the disease. These differences will be evaluated by the extraction of peripheral blood that will be analyzed before the treatment and after the treatment that, in the habitual way and at the discretion… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- VITILIGO
- What is being tested?
- CD 91 levels and Tregs
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 27 Oct 2015to 13 Sep 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18 to 65 years-old both sex
Who may be able to join
- Patient with vitiligo without treatment
Who cannot join
- Patient with inmunosupressive disease
- Patient receiving vitiligo treatment
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate some differences in the immune system between patients with vitiligo and patients without the disease.
These differences will be evaluated by the extraction of peripheral blood that will be analyzed before the treatment and after the treatment that, in the habitual way and at the discretion of the responsible dermatologist.
Read more
Patients agreeing to participate in the study will be subjected to extraction of two tubes (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.
Therefore, neither treatment nor follow-up visits will be modified by participation, but will be the same whether or not participate in the study.
In the case of controls, two peripheral blood tubes (20ml) will be removed in a single participation.
Patients with vitiligo will also be asked to complete questionnaires to measure stress, depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12 weeks (+/- 5 days) of therapeutic intervention .
This study will include 20 patients with active non-segmental vitiligo and 10 controls without the disease. The duration of participation in this study will be 12 weeks (+/- 5 days) for patients with vitiligo and a single participation (extraction of 20 ml of peripheral venous blood) for the controls.
- Conditions
- VITILIGO
- Being tested
- CD 91 levels, Tregs
- Keywords
- TREGS, CD91, LRP1
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD 91 levelsDiagnostic test
TregsDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo untreated patients | Not described Receives: Diagnostic Test: CD 91 levels; Diagnostic Test: Tregs | |
| Control. Patients without vitiligo | Not described Receives: Diagnostic Test: CD 91 levels; Diagnostic Test: Tregs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tregs levels
Measured: Baseline
Tregs levels
Measured: 16 weeks
Secondary outcomes (2)
LRP1 (CD91) levels
Measured: Baseline
LRP1 (CD91) levels
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start27 Oct 2015
- Primary completion13 Sep 2016
- Study completion13 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VITILIGOStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249064
- Sponsor's protocol ID
- IIBSP-VIT-2015-69
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Piquero-Casals J, Martinez-Martinez L, Alomar A, Rozas-Munoz E, Juarez C, Puig L. LRP1/CD91 is highly expressed in monocytes from patients with vitiligo - even after repigmentation. Exp Dermatol. 2021 Mar;30(3):390-395. doi: 10.1111/exd.14249. Epub 2020 Dec 14.
PubMed 33249636
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo
- ClinicalTrials.gov ID
- NCT03249064
- Acronym / sponsor ID
- IIBSP-VIT-2015-69
- Conditions
- VITILIGO
- Keywords
- TREGS, CD91, LRP1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- 13 Sep 2016 (actual)
- First posted
- 15 Aug 2017 (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 aims to evaluate some differences in the immune system between patients with vitiligo and patients without the disease.
These differences will be evaluated by the extraction of peripheral blood that will be analyzed before the treatment and after the treatment that, in the habitual way and at the discretion of the responsible dermatologist.
Patients agreeing to participate in the study will be subjected to extraction of two tubes (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.
Therefore, neither treatment nor follow-up visits will be modified by participation, but will be the same whether or not participate in the study.
In the case of controls, two peripheral blood tubes (20ml) will be removed in a single participation.
Patients with vitiligo will also be asked to complete questionnaires to measure stress, depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12 weeks (+/- 5 days) of therapeutic intervention .
This study will include 20 patients with active non-segmental vitiligo and 10 controls without the disease. The duration of participation in this study will be 12 weeks (+/- 5 days) for patients with vitiligo and a single participation (extraction of 20 ml of peripheral venous blood) for the controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitiligo untreated patients | – | Diagnostic Test: CD 91 levels, Diagnostic Test: Tregs |
| Control. Patients without vitiligo | – | Diagnostic Test: CD 91 levels, Diagnostic Test: Tregs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18 to 65 years-old both sex
Key inclusion criteria (1 listed)
- Patient with vitiligo without treatment
Key exclusion criteria (2 listed)
- Patient with inmunosupressive disease
- Patient receiving vitiligo treatment
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 |
|---|---|---|
| CD 91 levels | Diagnostic test | Control. Patients without vitiligo, Vitiligo untreated patients |
| Tregs | Diagnostic test | Control. Patients without vitiligo, Vitiligo untreated patients |
Primary outcome
Tregs levels
Time frame: Baseline
Tregs levels
Time frame: 16 weeks
2 secondary outcomes
LRP1 (CD91) levels
Time frame: Baseline
LRP1 (CD91) levels
Time frame: 16 weeks
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 22 Aug 2017.
- Derived from this study: PubMed 33249636Piquero-Casals J, Martinez-Martinez L, Alomar A, Rozas-Munoz E, Juarez C, Puig L. LRP1/CD91 is highly expressed in monocytes from patients with vitiligo - even after repigmentation. Exp Dermatol. 2021 Mar;30(3):390-395. doi: 10.1111/exd.14249. Epub 2020 Dec 14.
- Individual participant dataSharing planned: Undecided
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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 VITILIGO, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 22 Aug 2017. 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 Spain. 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?
Tregs levels (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT03249064, which also lists 1 linked publication.
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 22 Aug 2017.