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

NCT ID: NCT05910138

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

case

Group Type: ACTIVE_COMPARATOR

Serum Interlukin-15

Intervention Type: DIAGNOSTIC_TEST

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

Serum Interlukin-21

Intervention Type: DIAGNOSTIC_TEST

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

control

Group Type: ACTIVE_COMPARATOR

Serum Interlukin-15

Intervention Type: DIAGNOSTIC_TEST

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

Serum Interlukin-21

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Serum Interlukin-15

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

Intervention Type: DIAGNOSTIC_TEST

Serum Interlukin-21

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

Intervention Type: DIAGNOSTIC_TEST

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Marina Samir George

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University hospitals

Sohag, , Egypt

Countries

Egypt

Central Contacts

Marina S George, Resident

Role: CONTACT

marian_goarge@med.sohag.edu.eg

01273016740

Hanan A Metwally, Professor

Role: CONTACT

01118872013

Facility Contacts

Magdy M Amin, Professor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 26235375 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21188017 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29769777 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30820130 (View on PubMed)

Other Identifiers

Soh-Med-23-06-05MS

Identifier Type: -

Identifier Source: org_study_id