VitiligoNCT05223738
Resident Memory T Cells in Vitiligo
An observational study of Vitiligo, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This study aims to detect the presence and diversity of Tissue resident memory T cell populations in early and late cases of generalized non-segmental Vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitiligo
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Dec 2020to 1 Feb 2022
- 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: Generalized Non-segmental Vitiligo
Who may be able to join
- - Patients with Generalized non-segmental Vitiligo ( lesions in more than one anatomical site ).
- Both genders.
- Early group: onset less than or equal 6 months.
- Late group: onset more than 6 months
Who cannot join
- Localized or Segmental Vitiligo.
- Age < 14 years.
- Pregnant females
- Patient who received treatment of any type within the last 3 months for the late group.
- Patients with other skin diseases or immunosuppression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Resident Memory T Cells in Early & Late Cases of Generalized Non-segmental Vitiligo
This study aims to detect the presence and diversity of Tissue resident memory T cell populations in early and late cases of generalized non-segmental Vitiligo.
Read the detailed description
- Written informed consent obtained from every participant.
- Detailed history taking including onset, course, duration of the disease, aggravating factors and received medications
- VASI score assessed in every patient.
- Patients photographed, divided into two groups early \& late cases and 3 mm punch biopsies will be taken from perilesional and non lesional skin.
- Biopsies processed and stained for CD8 \& CD69 in cases of early group, \& late group and controls by immunofluorescence.
- Conditions
- Vitiligo
- Medical subject headings
- Vitiligo
What is being measured
The primary outcome is the main question the study is designed to answer.
CD8+ immunofluorescence
Number of Tissue resident Memory cells by positively stained by CD8+ in early and late generalized non segmental vitiligo patients
Measured: 6months-1 year
CD69+ immunofluorescence
Number of Tissue resident Memory cells by positively stained by CD8+ in early and late generalized non segmental vitiligo patients
Measured: 6months-1 year
Double CD8+ and CD69+ immunofluorescence
Number of Tissue resident Memory cells by double stained by CD8+ \&CD 69+ in early and late generalized non segmental vitiligo patients
Measured: 6months-1 year
VASI
Vitiligo Area and Severity index minimum 0 maximum 100, the larger the number the worse the condition
Measured: 6months-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start31 Dec 2020
- Primary completion30 Mar 2021
- Study completion1 Feb 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.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana F Hilal, MD, Kasr El Aini Hospital
- Investigators
- Hilal, Principal investigator, Kasr El Ainy University Hospital, Faculty of medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223738
- Sponsor's protocol ID
- TRMvit
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 4 Feb 2022
- 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 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Resident Memory T Cells in Early & Late Cases of Generalized Non-segmental Vitiligo
- ClinicalTrials.gov ID
- NCT05223738
- Acronym / sponsor ID
- TRMvit
- Conditions
- Vitiligo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 4 Feb 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.
This study aims to detect the presence and diversity of Tissue resident memory T cell populations in early and late cases of generalized non-segmental Vitiligo.
Detailed description
- Written informed consent obtained from every participant.
- Detailed history taking including onset, course, duration of the disease, aggravating factors and received medications
- VASI score assessed in every patient.
- Patients photographed, divided into two groups early \& late cases and 3 mm punch biopsies will be taken from perilesional and non lesional skin.
- Biopsies processed and stained for CD8 \& CD69 in cases of early group, \& late group and controls by immunofluorescence.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Generalized Non-segmental Vitiligo
Key inclusion criteria (4 listed)
- - Patients with Generalized non-segmental Vitiligo ( lesions in more than one anatomical site ).
- Both genders.
- Early group: onset less than or equal 6 months.
- Late group: onset more than 6 months
Key exclusion criteria (5 listed)
- Localized or Segmental Vitiligo.
- Age < 14 years.
- Pregnant females
- Patient who received treatment of any type within the last 3 months for the late group.
- Patients with other skin diseases or immunosuppression
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
CD8+ immunofluorescence
Time frame: 6months-1 year
Number of Tissue resident Memory cells by positively stained by CD8+ in early and late generalized non segmental vitiligo patients
CD69+ immunofluorescence
Time frame: 6months-1 year
Number of Tissue resident Memory cells by positively stained by CD8+ in early and late generalized non segmental vitiligo patients
Double CD8+ and CD69+ immunofluorescence
Time frame: 6months-1 year
Number of Tissue resident Memory cells by double stained by CD8+ \&CD 69+ in early and late generalized non segmental vitiligo patients
VASI
Time frame: 6months-1 year
Vitiligo Area and Severity index minimum 0 maximum 100, the larger the number the worse the condition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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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.
Hilal principal investigator
Kasr El Ainy University Hospital, Faculty of medicine, Cairo University
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 Kasr El Aini Hospital at 1 site in Egypt.
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 4 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 4 Feb 2022. 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 Egypt. 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?
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?
CD8+ immunofluorescence (time frame: 6months-1 year). The study lists 4 primary outcomes in all. 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 4 Feb 2022.