CompletedNot Applicable

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

Thailand11 participantsStarted 2023-11-29

Plain-language 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. 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: 16 weeks after taking oral Tofacitinib

Trial details

NCT IDNCT06202560

SponsorInstitute of Dermatology, Thailand

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-07-10

Results submitted2024-07-16

View on ClinicalTrials.gov More Frontal Fibrosing Alopecia trials