Completed

TofacitinibEffectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study

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What is being tested

Tofacitinib 5 MG

Drug
Who is being recruted

Lichen Planus+2

+ Skin Diseases

+ Skin and Connective Tissue Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2023
See protocol details

Summary

Principal SponsorInstitute of Dermatology, Thailand
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 29, 2023

Actual date on which the first participant was enrolled.

The study focuses on evaluating the effectiveness and safety of a medication called Tofacitinib for individuals suffering from Frontal Fibrosing Alopecia, a condition causing hair loss on the scalp and sometimes other areas. This specific condition can be stubborn and difficult to treat, so the study aims to find out if Tofacitinib can help improve symptoms like hair thinning and skin changes. Participants in this study include those with recalcitrant (hard-to-treat) cases of the condition, providing hope for those who have not found relief with other treatments. Participants take Tofacitinib orally at a dose of 5 mg twice daily for 12 weeks. They attend follow-up visits every 4 weeks during treatment and continue to be monitored for another 4 weeks after stopping the medication, making the total study duration 16 weeks. Researchers assess improvements in symptoms using various methods, including photography and specialized skin examinations, to ensure accurate results. Safety is also closely monitored through regular blood tests and evaluations of any side effects, such as infections or skin issues, ensuring the well-being of participants throughout the study.

Official TitleEffectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study
NCT06202560
Principal SponsorInstitute of Dermatology, Thailand
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lichen PlanusSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousLichenoid Eruptions

Criteria

Inclusion Criteria: 1. Thai males or females who were at least 18 years old 2. Participants who were diagnosed with frontal fibrosing alopecia The criteria for the diagnosis of frontal fibrosis alopecia are 2 major criteria or 1 major criterion plus 2 minor criteria. (Vañó-Galván et al., 2014) 3. Participants who were diagnosed with recalcitrant frontal fibrosing alopecia * The patient who fails treatment of at least one drug, such as hydroxychloroquine, and/or receives others, such as immunosuppressive drugs, pioglitazone, and retinoids. However, the symptoms of FFA still appear, such as perifollicular erythematous and/or scale, after taking treatment for more than 3 months * The patient continued taking the medicine as prescribed and coming to follow-up * The patient still has the medical record, such as a picture and dermoscopy * The patient does not need a washout time from the current medicine Exclusion Criteria: 1. Patients who were diagnosed with a disease that may relate to hair growth within six months, such as thyroid disease, iron deficiency anemia, liver disease, heart disease, neurological system disease, gastroenteritis disease, sexual disease, cancer, and psychologic disease 2. Pregnancy 3. Patients who have contraindications to take oral Tofacitinib such as severe infection, allergy to Tofacitinib, venous thromboembolism, leukopenia, severe liver disease, severe kidney failure, pneumonia, cancer 4. Patients who received strong or moderate to strong CYP3A4 agents 5. Patients who had positive on HBsAg and/or HCV

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
taking oral Tofacitinib 5 mg twice a day for 12 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hair and Nail center, Institute of Dermatology

Bangkok, ThailandOpen Hair and Nail center, Institute of Dermatology in Google Maps
CompletedOne Study Center