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Completed

NCT Number: NCT07645430

Assessment of Interleukin-15 and Interferon Gamma in Alopecia Areata Before and After Baricitinib.

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Benha University (Dermatology department)

Banhā, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Baricitinib 4 MG Oral Tablet

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Changes in the Severity of Alopecia Tool (SALT) score

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

    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%).

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Assessment of Serum Level of Interleukin-15 and Interferon Gamma in Alopecia Areata Patients Before and After Baricitinib Treatment

Acronym: Alopecia

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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