Evaluation of Serum Levels of Interlukin-15 and Interlukin-21 in Patients With Alopecia Areata

NCT05910138 | Unknown

• 1 other identifier: Soh-Med-23-06-05MS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (2)

• Evaluation of Serum levels of Interlukin-15

  Detection of its relation to activity and severity of Alopecia Areata

  12 months

• Evaluation of Serum levels of Interlukin-21

  Detection of its relation to activity and severity of Alopecia Areata

  12 months

Study Arms (2)

case

ACTIVE COMPARATOR

Diagnostic Test: Serum Interlukin-15; Diagnostic Test: Serum Interlukin-21

control

ACTIVE COMPARATOR

Diagnostic Test: Serum Interlukin-15; Diagnostic Test: Serum Interlukin-21

Interventions

Serum Interlukin-15 DIAGNOSTIC_TEST

Evaluate its serum level and detect its relation to the activity and severity of Alopecia Areata.

case; control

Serum Interlukin-21 DIAGNOSTIC_TEST

Evaluate its serum level and detect its relation to the activity and severity of Alopecia Areata.

case; control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sex with active and stable AA.

You may not qualify if:

• Pregnant patients.
• Lactating patients.
• Patients with other differential diagnoses of AA (Trichotillomania, temporal triangular alopecia, and tinea capitis).

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 26235375 BACKGROUND

• 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.

  PMID: 21188017 BACKGROUND

• 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.

  PMID: 29769777 BACKGROUND

• 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.

  PMID: 30820130 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Marina S George, Resident

CONTACT

01273016740; marian_goarge@med.sohag.edu.eg

Hanan A Metwally, Professor

CONTACT

01118872013

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

EG (1)