Back to resultsRole of NGAL in Vitiligo
Primary Purpose
Vitiligo
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
NGAL
Sponsored by
About this trial
This is an interventional screening trial for Vitiligo focused on measuring NGAL & CVR
Eligibility Criteria
Inclusion Criteria:
- patients with vitiligo above 20y
Exclusion Criteria:
- patients with systemic disease Pregnants female Lactating females Patients less than 20 y Patients with active lesions
Sites / Locations
- Sohag fuculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cases
control group
Arm Description
group of vitiligo patients
healthy group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05290077
Brief Title
Role of NGAL in Vitiligo
Official Title
Role of Serum NGAL Inearly Detection of CVR in Patients With Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2022 (Anticipated)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
NGAL & CVR
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Active Comparator
Arm Description
group of vitiligo patients
Arm Title
control group
Arm Type
Active Comparator
Arm Description
healthy group
Intervention Type
Diagnostic Test
Intervention Name(s)
NGAL
Intervention Description
Serum NGAL in blood for early detection of CVR
Primary Outcome Measure Information:
Title
serum Neutrophil Gelatinase-associated Lipocalin in patients with Vitilig
Description
Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with vitiligo above 20y
Exclusion Criteria:
patients with systemic disease Pregnants female Lactating females Patients less than 20 y Patients with active lesions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa G Hafez, resident
Phone
01062472611
Email
Doaag63@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa M Abd El-Meged, professor
Facility Information:
Facility Name
Sohag fuculty
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25596811
Citation
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.
Results Reference
background
PubMed Identifier
28828385
Citation
Vachiramon 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.
Results Reference
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PubMed Identifier
23560296
Citation
Silverberg 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.
Results Reference
background
PubMed Identifier
32463851
Citation
Mazzei Weiss ME. Vitiligo: to biopsy or not to biopsy? Cutis. 2020 Apr;105(4):189-190. No abstract available.
Results Reference
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Role of NGAL in Vitiligo
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