Trial Outcomes & Findings for Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study (NCT NCT06202560)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

16 weeks after taking oral Tofacitinib

Results posted on

2025-05-30

Participant Flow

Recalcitrant frontal fibrosing alopecia patients who were confirmed diagnosed. Participants were out-patients treated at the Hair and Nail Center, the Institute of Dermatology, from November 2023 to March 2024 and qualified for inclusion criteria.

If abnormal blood test results are found during each follow-up visit, such as a 3-fold increase in liver enzymes (AST and/or ALT) from the baseline, consideration should be given to stop taking tofacitinib immediately.

Participant milestones

Participant milestones
Measure	Tofacitinib oral tofacitinib 5 mg twice a day for 12 weeks 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 weeks 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.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib n=11 Participants taking oral Tofacitinib 5 mg twice a day for 12 weeks 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized asian	11 participants n=5 Participants
Region of Enrollment Thailand	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks after taking oral Tofacitinib

Population: The effectiveness of tofacitinib for FFA was assessed by comparing the Frontal Fibrosing Alopecia Severity Index (FFASI) (ranging from 0 to 100), Frontal Fibrosing Alopecia Severity Score (FFASS) (ranging from 0 to 25), and Lichen Planopilaris Activity Index (LPPAI) (ranging from 0 to 10) between baseline (week 0) and week 16. Lower scores across these indices indicated greater treatment effectiveness. Two independent dermatologists reviewed patient photographs to determine improvements.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib n=11 Participants taking oral Tofacitinib 5 mg twice a day for 12 weeks 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.
Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) FFASI at baseline (week 0)	47.5 score on a scale Standard Deviation 13.25
Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) FFASI at week 16	44 score on a scale Standard Deviation 13.5
Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) FFASS at baseline (week 0)	16.3 score on a scale Standard Deviation 4.07
Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) FFASS at week 16	15.9 score on a scale Standard Deviation 4.62
Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) LPPAI at baseline (week 0)	1.83 score on a scale Standard Deviation 1.01
Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) LPPAI at week 16	1.33 score on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: 16 weeks after taking oral Tofacitinib

Outcome measures

Outcome measures
Measure	Tofacitinib n=11 Participants taking oral Tofacitinib 5 mg twice a day for 12 weeks 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.
Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA) mild acne vulgaris	4 participants
Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA) hypercholesterolemia	5 participants

Adverse Events

Tofacitinib

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tofacitinib n=11 participants at risk taking oral Tofacitinib 5 mg twice a day for 12 weeks 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.
Investigations hypercholesterolemia	45.5% 5/11 • Number of events 5 • 16 weeks
Skin and subcutaneous tissue disorders Acne	36.4% 4/11 • Number of events 5 • 16 weeks
Musculoskeletal and connective tissue disorders Headache	9.1% 1/11 • Number of events 1 • 16 weeks
Musculoskeletal and connective tissue disorders Fatique	9.1% 1/11 • Number of events 1 • 16 weeks

Additional Information

Chinmanat Lekhavat

Institute of dermatology, Thailand

Phone: +66 95-207-2870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place