Back to resultsEvaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo
Primary Purpose
Vitiligo
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interleukin-15 and Interleukin-22
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitiligo
Eligibility Criteria
Inclusion Criteria:
• Patients suffering from non segmental vitiligo.
- Patients not on medical treatment or phototherapy for vitiligo in the last 3 months.
Exclusion Criteria:
• Patients with systemic or cutaneous inflammatory disorders.
- Patients on treatment for vitiligo in last 3 months.
- Pregnant and lactating patients.
- Patients with history of diabetes.
- Patients with history of autoimmune diseases.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
non segmental vitiligo
normal volunteer
Arm Description
serum analysis
serum analysis
Outcomes
Primary Outcome Measures
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels
3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate
Serum IL15 level .
Serum IL22 level. 3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate
1. Serum IL15 level . 2. Serum IL22 level.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05121532
Brief Title
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo
Official Title
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 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
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients with Non-segmental Vitiligo before and after phototherapy
Detailed Description
This prospective study will include 30 patients with NSV, attending the Outpatient Clinics of Dermatology at Sohag University Hospitals, as well as 30 normal volunteers as control.
This study will be submitted for approval by Research and Ethical committees at Sohag Faculty of Medicine. An informed written consent will be obtained from each subject prior to participation in the study after full explanation of the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
non segmental vitiligo
Arm Type
Active Comparator
Arm Description
serum analysis
Arm Title
normal volunteer
Arm Type
Active Comparator
Arm Description
serum analysis
Intervention Type
Diagnostic Test
Intervention Name(s)
Interleukin-15 and Interleukin-22
Intervention Description
Serum Interleukin-15 and Interleukin-22 in non segmental vitiligo
Primary Outcome Measure Information:
Title
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels
Description
3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate
Serum IL15 level .
Serum IL22 level. 3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate
1. Serum IL15 level . 2. Serum IL22 level.
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Patients suffering from non segmental vitiligo.
Patients not on medical treatment or phototherapy for vitiligo in the last 3 months.
Exclusion Criteria:
• Patients with systemic or cutaneous inflammatory disorders.
Patients on treatment for vitiligo in last 3 months.
Pregnant and lactating patients.
Patients with history of diabetes.
Patients with history of autoimmune diseases.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo
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