N/A
N=11
Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study
Frontal Fibrosing Alopecia · Lichen Planopilaris of Scalp
Bottom Line
View on ClinicalTrials.gov: NCT06202560 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) — 47.5; 44; 16.3; 15.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tofacitinib 5 MG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institute of Dermatology, Thailand
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) |
47.5; 44; 16.3; 15.9; 1.83; 1.33 | — |
| SECONDARY Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA) |
4; 5 | — |
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.
Eligibility Criteria
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
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT06202560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.