Alopecia AreataNCT05910138
Evaluation of Serum Levels of Interlukin-15 and Interlukin-21 in Patients With Alopecia Areata
A study testing Serum Interlukin-15 and Serum Interlukin-21 in people with Alopecia Areata, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Serum Interlukin-15 and Serum Interlukin-21
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both sex with active and stable AA.
Who cannot join
- -Pregnant patients.
- Lactating patients.
- Patients with other differential diagnoses of AA (Trichotillomania, temporal triangular alopecia, and tinea capitis).
Trial locations and contacts
1 site in 1 country.
Hanan A Metwally, Professor contact
About this study
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.
Read more
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
- Being tested
- Serum Interlukin-15, Serum Interlukin-21
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Interlukin-15Diagnostic test
Evaluate its serum level and detect its relation to the activity and severity of Alopecia Areata.
Serum Interlukin-21Diagnostic test
Evaluate its serum level and detect its relation to the activity and severity of Alopecia Areata.
| Study group | Role | What they receive |
|---|---|---|
| case | Active comparator | Not described Receives: Diagnostic Test: Serum Interlukin-15; Diagnostic Test: Serum Interlukin-21 |
| control | Active comparator | Not described Receives: Diagnostic Test: Serum Interlukin-15; Diagnostic Test: Serum Interlukin-21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Serum levels of Interlukin-15
Detection of its relation to activity and severity of Alopecia Areata
Measured: 12 months
Evaluation of Serum levels of Interlukin-21
Detection of its relation to activity and severity of Alopecia Areata
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Samir George, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910138
- Sponsor's protocol ID
- Soh-Med-23-06-05MS
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26235375Chaitra 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.
PubMed 21188017Darwin 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.
PubMed 29769777Ebrahim 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.
PubMed 30820130
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Levels of Interlukin-15 and Interlukin-21 in Patients With Alopecia Areata
- ClinicalTrials.gov ID
- NCT05910138
- Acronym / sponsor ID
- Soh-Med-23-06-05MS
- Conditions
- Alopecia Areata
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both sex with active and stable AA.
Key exclusion criteria (3 listed)
- -Pregnant patients.
- Lactating patients.
- Patients with other differential diagnoses of AA (Trichotillomania, temporal triangular alopecia, and tinea capitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Interlukin-15Evaluate its serum level and detect its relation to the activity and severity of Alopecia Areata. | Diagnostic test | case, control |
| Serum Interlukin-21Evaluate its serum level and detect its relation to the activity and severity of Alopecia Areata. | Diagnostic test | case, control |
Primary outcome
Evaluation of Serum levels of Interlukin-15
Time frame: 12 months
Detection of its relation to activity and severity of Alopecia Areata
Evaluation of Serum levels of Interlukin-21
Time frame: 12 months
Detection of its relation to activity and severity of Alopecia Areata
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 26235375Atwa 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.
- Background: PubMed 21188017Chaitra 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.
- Background: PubMed 29769777Darwin 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.
- Background: PubMed 30820130Ebrahim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanan A Metwally, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum Interlukin-15 and Serum Interlukin-21 in people with Alopecia Areata, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina S George, Resident (01273016740, marian_goarge@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Serum levels of Interlukin-15 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910138, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.