Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study (Tofacitinib)

January 1, 2024 updated by: Institute of Dermatology, Thailand

The goal of this study is to study the efficacy and safety of Tofacitinib therapy in Thai patients with recalcitrant frontal fibrosing alopecia.

The main questions are

  1. Does Tofacitinib significantly reduce Frontal Fibrosing Alopecia Severity Index (FFASI), Frontal Fibrosing Alopecia Severity Score (FFASS), Lichen planopillaris Activity Index (LPPAI) compared to baseline and after 16 weeks?
  2. Is Tofacitinib significantly different for adverse events compared to baseline and after 16 weeks? Participants will have a check-up in clinical and investigation and then get prescribed oral Tofacitinib 5 mg twice a day for 12 weeks. After that, they will have follow-up every 4 weeks until week 16.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

1.The researcher collects personal data including age, gender, weight, height, body mass index, waist circumference, personal medical history, history of medication use in the past 3 months (menstruation history for female subjects), as well as records of symptoms such as hair loss history and diagnosis, pattern of hair loss on the scalp or other areas, comorbidities, family history, and other accompanying symptoms.

2.The researchers require the patients to undergo various blood tests before receiving treatment.

3. The researchers collect data on the patients' skin conditions using Digital Camera and a Dermoscope. They capture images of the scalp, eyebrows, eyelashes, facial rashes, joint folds, arms, legs, nails, mouth, and dark spots (if present).

4.Participants in the research will receive oral Tofacitinib medication with a dosage of 5 mg, twice a day, for 12 weeks. They will be scheduled to come for follow-up every 4 weeks throughout the 12-week period, and will continue to be followed up for 4 weeks after stopping the medication. The total duration of the research will be 16 weeks. The purpose is to evaluate the effectiveness and safety of the medication.

  1. The symptoms of the disease to be assessed include facial papule, LP pigmentosus, pruritus, trichodynia, perifollicular erythema, and perifollicular hyperkeratosis.
  2. Frontal Fibrosing Alopecia Severity Index (FFASI)
  3. Frontal Fibrosing Alopecia Severity Score (FFASS)
  4. Lichen Planopillaris Activity Index (LPPAI)
  5. The photograph will be taken. The areas photographed include the scalp, eyebrows, eyelashes, facial rashes, joint folds, arms, legs, nails, dark spots (if present), and mouth. Two expert physicians will evaluate the photographs independently, and the photographs of 10 patients were assessed to determine the consistency among the physicians before evaluating the actual patients. The evaluation will determine whether the patient's conditions have improved, remained stable, or worsened.
  6. Dermoscopy will be performed. The areas examined include the scalp, eyebrows, eyelashes, facial rashes, joint folds, arms, legs, nails, dark spots (if present), and mouth.
  7. The patient's abnormal symptoms after medication administration will be evaluated, including respiratory tract infections, skin abnormalities, gastrointestinal abnormalities, urinary tract infections, or other symptoms.
  8. Laboratory tests will be conducted to assess the safety of the medication at weeks 4, 12, and 16.

Study Type

Interventional

Enrollment (Estimated)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Hair and Nail center, Institute of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tofacitinib
taking oral Tofacitinib 5 mg twice a day for 12 weeks
Drug: Tofacitinib 5 MG
Participants in the research will receive oral Tofacitinib medication with a dosage of 5 mg, twice a day, for 12 weeks. They will be scheduled to come for follow-up every 4 weeks throughout the 12-week period, and will continue to be followed up for 4 weeks after stopping the medication. The total duration of the research will be 16 weeks. The purpose is to evaluate the effectiveness and safety of the medication.
Other Names:
  • Xeljanz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of oral tofacitinib in recalcitrant Frontal Fibrosing Alopecia(FFA)
Time Frame: 16 weeks after taking oral Tofacitinib
The effectiveness of this study will be evaluated by comparing the Frontal Fibrosing Alopecia Severity Index (FFASI) (Max score = 100 and Min score = 0), Frontal Fibrosing Alopecia Severity Score (FFASS) (Max score = 25 and Min score = 0), and Lichen Planopilaris Activity Index (LPPAI) (Max score = 10 and Min score = 0) between week 0 (baseline week) and week 16. If a patient has a lower score on all of these indices, it means the treatment is more effective. In addition, two expert physicians will independently evaluate the photographs. The two evaluators will determine whether the patient's conditions have improved, remained stable, or worsened.
16 weeks after taking oral Tofacitinib

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical & Investigation Safety of oral tofacitinib in recalcitrant (FFA)
Time Frame: 16 weeks after taking oral Tofacitinib
The safety of clinical and laboratory investigation and oral Tofacitinib treatment is evident, as patients do not experience any complaints of abnormal symptoms after taking the drugs. These symptoms may include respiratory tract infections, skin abnormalities, gastrointestinal abnormalities, urinary tract infections, or other adverse events at weeks 4, 12, and 16.
16 weeks after taking oral Tofacitinib

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Dermatology, Thailand

Investigators

  • Study Director: Chinmanat Lekhavat, MD, Institute of Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Estimated)

April 5, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

November 26, 2023

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/IEC 022/2566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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