Evaluation of Serum Levels of Interlukin-15 and Interlukin-21 in Patients With Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serum Interlukin-15
Serum Interlukin-21
Sponsored by
About this trial
This is an interventional diagnostic trial for Alopecia Areata
Eligibility Criteria
Inclusion Criteria: Patients of both sex with active and stable AA. Exclusion Criteria: -Pregnant patients. Lactating patients. Patients with other differential diagnoses of AA (Trichotillomania, temporal triangular alopecia, and tinea capitis).
Sites / Locations
- Sohag University hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
case
control
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of Serum levels of Interlukin-15
Detection of its relation to activity and severity of Alopecia Areata
Evaluation of Serum levels of Interlukin-21
Detection of its relation to activity and severity of Alopecia Areata
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05910138
Brief Title
Evaluation of Serum Levels of Interlukin-15 and Interlukin-21 in Patients With Alopecia Areata
Official Title
Evaluation of Serum Levels of Interlukin-15 and Interlukin-21 in Patients With Alopecia Areata
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (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
Alopecia areata (AA) is a type of non-cicatricial alopecia. The most common presentation of AA is localized patches of hair loss on the scalp. The extensive forms of AA presented as diffuse hair loss of the scalp (alopecia totalis) and diffuse hair loss through the entire body including the eyelashes and eyebrows (alopecia universalis).
AA affects approximately 2% of the general population. AA occurs at any age. The peak of incidence is higher in the second and third decades of life.
AA may be associated with several autoimmune diseases including thyroid diseases, lupus erythematosus, vitiligo, psoriasis, rheumatoid arthritis and inflammatory bowel disease. The frequency of the disease varies between geographically separate populations. These diseases associations suggest a relationship between AA and autoimmunity.
Human hair has an important cosmetic and communicational role. We may find significant psychological distress in persons with partial and complete hair loss. AA is associated with psychiatric morbidity especially anxiety and depression.
The pathogenesis of AA involves a complex interaction between genetic, environmental and immune factors. The histopathology of the disease differs according to the stage of the disease. In the acute stage of AA, there is a dense accumulation of lymphocytes (CD4 &CD8) around hair bulbs so called swarm of bees. In chronic stage, the inflammation may or may not resolve, but there is increase in number of catagen and, or telogen hair and pigmentary incontinence. In the recovery stage, there is minimal inflammation and increase in anagen hair.
T-helper17 cells are unique subset of T-helper cells which produce many interleukins (IL) e.g. IL-17A, IL-17F, IL-21, IL-22, IL-6 and tumor necrosis factor (TNF). The maturation of Th-17 needs the stimulation of naïve T cells by both TGF and IL-21. IL-21 is a cytokine that is produced mostly by activated CD4 T cells. It controls the differentiation and activity of T cells, B cells and NK cells. IL-21 could be a promising marker in the diagnosis of AA and also can be used as a marker of its activity.
IL-15 is a pleotropic cytokine that has multiple effects on different body cell types. It affects the function of cells of both innate and adaptive immune system. IL-15 is well known to promote lymphocytic development and suggested to play a role in some autoimmune diseases e.g. multiple sclerosis, rheumatoid arthritis, ulcerative colitis and celiac disease. IL-15 inhibits the well-known self-tolerance that mediated by activation - induced cell death, promotes maintenance of CD8+ memory T cells with induction of some cytokines which involved in autoimmune process e.g. TNF- and IL-1B. IL-15 is positively correlated with the number and the extent of AA so it could be a possible marker of AA severity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
case
Arm Type
Active Comparator
Arm Title
control
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum Interlukin-15
Intervention Description
Evaluate its serum level and detect its relation to the activity and severity of Alopecia Areata.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum Interlukin-21
Intervention Description
Evaluate its serum level and detect its relation to the activity and severity of Alopecia Areata.
Primary Outcome Measure Information:
Title
Evaluation of Serum levels of Interlukin-15
Description
Detection of its relation to activity and severity of Alopecia Areata
Time Frame
12 months
Title
Evaluation of Serum levels of Interlukin-21
Description
Detection of its relation to activity and severity of Alopecia Areata
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both sex with active and stable AA.
Exclusion Criteria:
-Pregnant patients.
Lactating patients.
Patients with other differential diagnoses of AA (Trichotillomania, temporal triangular alopecia, and tinea capitis).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina S George, Resident
Phone
01273016740
Email
marian_goarge@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan A Metwally, Professor
Phone
01118872013
Facility Information:
Facility Name
Sohag University hospitals
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26235375
Citation
Atwa MA, Youssef N, Bayoumy NM. T-helper 17 cytokines (interleukins 17, 21, 22, and 6, and tumor necrosis factor-alpha) in patients with alopecia areata: association with clinical type and severity. Int J Dermatol. 2016 Jun;55(6):666-72. doi: 10.1111/ijd.12808. Epub 2015 Jul 31.
Results Reference
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PubMed Identifier
21188017
Citation
Chaitra V, Rajalakshmi T, Kavdia R. Histopathologic profile of alopecia areata in Indian patients. Int J Trichology. 2010 Jan;2(1):14-7. doi: 10.4103/0974-7753.66906.
Results Reference
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PubMed Identifier
29769777
Citation
Darwin E, Hirt PA, Fertig R, Doliner B, Delcanto G, Jimenez JJ. Alopecia Areata: Review of Epidemiology, Clinical Features, Pathogenesis, and New Treatment Options. Int J Trichology. 2018 Mar-Apr;10(2):51-60. doi: 10.4103/ijt.ijt_99_17.
Results Reference
background
PubMed Identifier
30820130
Citation
Ebrahim AA, Salem RM, El Fallah AA, Younis ET. Serum Interleukin-15 is a Marker of Alopecia Areata Severity. Int J Trichology. 2019 Jan-Feb;11(1):26-30. doi: 10.4103/ijt.ijt_80_18.
Results Reference
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Evaluation of Serum Levels of Interlukin-15 and Interlukin-21 in Patients With Alopecia Areata
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