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

NCT06202560 | Completed Results

• 1 other identifier: IRB/IEC 022/2566
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the efficacy and safety of tofacitinib therapy in Thai patients with recalcitrant frontal fibrosing alopecia. The main questions are

1. 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. 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.

Conditions

Frontal Fibrosing Alopecia; Lichen Planopilaris of Scalp

Keywords

Tofacitinib; Frontal Fibrosing Alopecia Severity Index (FFASI); Frontal Fibrosing Alopecia Severity Score (FFASS); Lichen Planopilaris Activity Index (LPPAI); Frontal fibrosing alopecia; Lichen planopilaris

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA)

  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 Outcomes (1)

• Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA)

  16 weeks after taking oral Tofacitinib

Study Arms (1)

Tofacitinib

EXPERIMENTAL

taking oral Tofacitinib 5 mg twice a day for 12 weeks

Drug: Tofacitinib 5 MG

Interventions

Tofacitinib 5 MG DRUG

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.

Also known as: Xeljanz

Tofacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thai males or females who were at least 18 years old
• 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)
• 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

You may not qualify if:

• 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
• Pregnancy
• 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
• Patients who received strong or moderate to strong CYP3A4 agents
• Patients who had positive on HBsAg and/or HCV

Sponsors & Collaborators

• Institute of Dermatology, Thailand: lead

Study Sites (1)

Hair and Nail center, Institute of Dermatology

Bangkok, 10400, Thailand

Location

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MeSH Terms

Conditions

Lichen Planus

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chinmanat Lekhavat
• Organization: Institute of dermatology, Thailand

chinmanat@gmail.com

+66 95-207-2870

Study Officials

• Chinmanat Lekhavat, MD

  Institute of Dermatology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: January 11, 2024
• Study Start: November 29, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)