Alopecia AreataAlopeciaNCT07645430
Assessment of Interleukin-15 and Interferon Gamma in Alopecia Areata Before and After Baricitinib.
A study testing Baricitinib 4 MG Oral Tablet in people with Alopecia Areata, run by Benha University at 1 site in Egypt.
Trial summary
The primary objective of this study was to evaluate the change in serum interferon gamma and Interleukin-15 levels before and after use of oral drug baricitinib therapy. Venous blood samples (5 mL) were collected from each participant at baseline and at six months. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Baricitinib 4 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 9 Jun 2026
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults diagnosed clinically with Alopecia Areata.
- Severity of alopecia tool (SALT) score greater than 50.
- Only patients with disease duration exceeding six months but less than eight years will be included.
Who cannot join
- Patients were excluded if they were pregnant or lactating, and had chronic hepatic or renal disease.
- Cases diagnosed with malignancy, scalp infections, or other types of alopecia will also excluded from the current study.
- Recent use of systemic treatment within the last 3 months or topical treatment within the last 4 weeks also will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine, Benha University (Dermatology department)
Banhā, 13511
About this study
Official title: Assessment of Serum Level of Interleukin-15 and Interferon Gamma in Alopecia Areata Patients Before and After Baricitinib Treatment
The primary objective of this study was to evaluate the change in serum interferon gamma and Interleukin-15 levels before and after use of oral drug baricitinib therapy. Venous blood samples (5 mL) were collected from each participant at baseline and at six months.
Read the detailed description
Changes at baseline and immediately after 6 mmonths will be analyzed, primary outcome is the changes in serum levels over 6 months, while secondary outcome is changes in the Severity of Alopecia Tool (SALT score) over 6 months.
- Conditions
- Alopecia Areata
- Being tested
- Baricitinib 4 MG Oral Tablet
- Keywords
- Alopecia Areata, Baricitinib, Interleukin-15, Interferon Gamma
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib 4 MG Oral TabletDrug
All cases will use oral Baricitinab 4mg daily dose for six months.
| Study group | Role | What they receive |
|---|---|---|
| Alopecia Areata adults with severity of alopecia tool more than 50 percent. | Active comparator | Adults aged between 18 to 50 years and having a severity of alopecia tool (SALT) score more than 50 pecent. Receives: Drug: Baricitinib 4 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of Interleukin-15.
Measuring the serum level of Interleukin-15 at baseline and immediately after 6 months of Baricitinab 4mg oral therapy. Measurement is done using Enzyme-Linked Immunosorbent Assay (ELISA) laboratory technique.
Measured: At baseline and immediately after 6 months of follow up.
Serum level of Interferon Gamma.
Measuring the serum level of Interferon Gamma at baseline and immediately after 6 months of Baricitinab 4mg oral therapy. Measurement is done using Enzyme-Linked Immunosorbent Assay (ELISA) laboratory technique.
Measured: Baseline and immediately after 6 months of Baricitinab 4mg oral therapy.
Secondary outcomes (1)
Changes in the Severity of Alopecia Tool (SALT) score
Severity of Alopecia Tool (SALT) score is a standardized measurement used by dermatologists to quantify scalp hair loss, ranging from 0 (no hair loss) to 100 (complete baldness). It is calculated by adding the weighted percentages of hair loss from four scalp quadrants: vertex (40%), posterior (24%), right profile (18%), and left profile (18%).
Measured: At Baseline and immediately after 6 months of oral Baricitinab 4mg oral therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Benha 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Youssif Habashy, Benha University
- Investigators
- Amal Youssif Habashy, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645430
- Sponsor's protocol ID
- RC-1-24
- Acronym
- Alopecia
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is avialable upon request from the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum Level of Interleukin-15 and Interferon Gamma in Alopecia Areata Patients Before and After Baricitinib Treatment
- ClinicalTrials.gov ID
- NCT07645430
- Acronym / sponsor ID
- Alopecia / RC-1-24
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Baricitinib, Interleukin-15, Interferon Gamma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 12 Jun 2026 (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.
The primary objective of this study was to evaluate the change in serum interferon gamma and Interleukin-15 levels before and after use of oral drug baricitinib therapy. Venous blood samples (5 mL) were collected from each participant at baseline and at six months.
Detailed description
Changes at baseline and immediately after 6 mmonths will be analyzed, primary outcome is the changes in serum levels over 6 months, while secondary outcome is changes in the Severity of Alopecia Tool (SALT score) over 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alopecia Areata adults with severity of alopecia tool more than 50 percent. | Active comparator | Drug: Baricitinib 4 MG Oral TabletAdults aged between 18 to 50 years and having a severity of alopecia tool (SALT) score more than 50 pecent. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults diagnosed clinically with Alopecia Areata.
- Severity of alopecia tool (SALT) score greater than 50.
- Only patients with disease duration exceeding six months but less than eight years will be included.
Key exclusion criteria (3 listed)
- Patients were excluded if they were pregnant or lactating, and had chronic hepatic or renal disease.
- Cases diagnosed with malignancy, scalp infections, or other types of alopecia will also excluded from the current study.
- Recent use of systemic treatment within the last 3 months or topical treatment within the last 4 weeks also will be excluded.
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 |
|---|---|---|
| Baricitinib 4 MG Oral TabletAll cases will use oral Baricitinab 4mg daily dose for six months. | Drug | Alopecia Areata adults with severity of alopecia tool more than 50 percent. |
Primary outcome
Serum level of Interleukin-15.
Time frame: At baseline and immediately after 6 months of follow up.
Measuring the serum level of Interleukin-15 at baseline and immediately after 6 months of Baricitinab 4mg oral therapy. Measurement is done using Enzyme-Linked Immunosorbent Assay (ELISA) laboratory technique.
Serum level of Interferon Gamma.
Time frame: Baseline and immediately after 6 months of Baricitinab 4mg oral therapy.
Measuring the serum level of Interferon Gamma at baseline and immediately after 6 months of Baricitinab 4mg oral therapy. Measurement is done using Enzyme-Linked Immunosorbent Assay (ELISA) laboratory technique.
1 secondary outcome
Changes in the Severity of Alopecia Tool (SALT) score
Time frame: At Baseline and immediately after 6 months of oral Baricitinab 4mg oral therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. Data is avialable upon request from the principal investigator.
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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.
Amal Youssif Habashy, MD principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baricitinib 4 MG Oral Tablet in people with Alopecia Areata, run by Benha 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 3 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: finished, as of the sponsor's last update on 12 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of Interleukin-15. (time frame: At baseline and immediately after 6 months of follow up.). 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?
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 12 Jun 2026.