NCT07645430

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Alopecia AreataBaricitinibInterleukin-15Interferon Gamma

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and immediately after 6 months of Baricitinab 4mg oral therapy.

Secondary Outcomes (1)

  • Changes in the Severity of Alopecia Tool (SALT) score

    At Baseline and immediately after 6 months of oral Baricitinab 4mg oral therapy.

Study Arms (1)

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.

Drug: Baricitinib 4 MG Oral Tablet

Interventions

All cases will use oral Baricitinab 4mg daily dose for six months.

Alopecia Areata adults with severity of alopecia tool more than 50 percent.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Benha University (Dermatology department)

Banhā, 13511, Egypt

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

baricitinib

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Amal Youssif Habashy, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Amal Youssif Habashy

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 12, 2026

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

June 9, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Data is avialable upon request from the principal investigator.

Locations