VitiligoNCT05290077
Role of NGAL in Vitiligo
A study testing NGAL in people with Vitiligo, run by Sohag University at 1 site in Egypt.
Trial summary
Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- NGAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 15 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with vitiligo above 20y
Who cannot join
- patients with systemic disease Pregnants female Lactating females Patients less than 20 y Patients with active lesions
Trial locations and contacts
1 site in 1 country.
Marwa M Abd El-Meged, professor contact
About this study
Official title: Role of Serum NGAL Inearly Detection of CVR in Patients With Vitiligo
Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo
- Conditions
- Vitiligo
- Being tested
- NGAL
- Keywords
- NGAL & CVR
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGALDiagnostic test
Serum NGAL in blood for early detection of CVR
| Study group | Role | What they receive |
|---|---|---|
| Cases | Active comparator | group of vitiligo patients Receives: Diagnostic Test: NGAL |
| control group | Active comparator | healthy group Receives: Diagnostic Test: NGAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Neutrophil Gelatinase-associated Lipocalin in patients with Vitilig
Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Gamal Hafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290077
- Sponsor's protocol ID
- Soh-Med-21-10-20
- Status last verified
- Dec 2021
- First submitted
- 7 Nov 2021
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
PubMed 25596811Vachiramon V, Onprasert W, Harnchoowong S, Chanprapaph K. Prevalence and Clinical Characteristics of Itch in Vitiligo and Its Clinical Significance. Biomed Res Int. 2017;2017:5617838. doi: 10.1155/2017/5617838. Epub 2017 Jul 30.
PubMed 28828385Silverberg JI, Silverberg NB. Association between vitiligo extent and distribution and quality-of-life impairment. JAMA Dermatol. 2013 Feb;149(2):159-64. doi: 10.1001/jamadermatol.2013.927.
PubMed 23560296Mazzei Weiss ME. Vitiligo: to biopsy or not to biopsy? Cutis. 2020 Apr;105(4):189-190. No abstract available.
PubMed 32463851
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Serum NGAL Inearly Detection of CVR in Patients With Vitiligo
- ClinicalTrials.gov ID
- NCT05290077
- Acronym / sponsor ID
- Soh-Med-21-10-20
- Conditions
- Vitiligo
- Keywords
- NGAL & CVR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 22 Mar 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.
Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Active comparator | Diagnostic Test: NGALgroup of vitiligo patients |
| control group | Active comparator | Diagnostic Test: NGALhealthy group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with vitiligo above 20y
Key exclusion criteria (1 listed)
- patients with systemic disease Pregnants female Lactating females Patients less than 20 y Patients with active lesions
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 |
|---|---|---|
| NGALSerum NGAL in blood for early detection of CVR | Diagnostic test | Cases, control group |
Primary outcome
serum Neutrophil Gelatinase-associated Lipocalin in patients with Vitilig
Time frame: 6 months
Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Background: PubMed 25596811Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
- Background: PubMed 28828385Vachiramon V, Onprasert W, Harnchoowong S, Chanprapaph K. Prevalence and Clinical Characteristics of Itch in Vitiligo and Its Clinical Significance. Biomed Res Int. 2017;2017:5617838. doi: 10.1155/2017/5617838. Epub 2017 Jul 30.
- Background: PubMed 23560296Silverberg JI, Silverberg NB. Association between vitiligo extent and distribution and quality-of-life impairment. JAMA Dermatol. 2013 Feb;149(2):159-64. doi: 10.1001/jamadermatol.2013.927.
- Background: PubMed 32463851Mazzei Weiss ME. Vitiligo: to biopsy or not to biopsy? Cutis. 2020 Apr;105(4):189-190. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Vitiligo
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A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
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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.
Marwa M Abd El-Meged, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGAL in people with Vitiligo, run by Sohag University 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 1 inclusion and 1 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 31 Oct 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?
Contact Doaa G Hafez, resident (01062472611, Doaag63@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum Neutrophil Gelatinase-associated Lipocalin in patients with Vitilig (time frame: 6 months). 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 NCT05290077, which also lists 4 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 31 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.