Trial results for a pilot study investigating tofacitinib (Xeljanz, Xeljanz XR) in patients with recalcitrant frontal fibrosing alopecia and lichen planopilaris of the scalp were posted on ClinicalTrials.gov on 2025-05-30. The study enrolled 11 participants and reported median scores for effectiveness and safety outcomes.
Background
The pilot study aimed to determine the efficacy and safety of tofacitinib therapy in Thai patients with recalcitrant frontal fibrosing alopecia. The study also included patients with lichen planopilaris of the scalp.
Trial design
The pilot study (NCT06202560) was a single-arm study with an overall status of COMPLETED, enrolling 11 participants. The study investigated tofacitinib 5 mg in patients with recalcitrant frontal fibrosing alopecia and lichen planopilaris of the scalp. The study aimed to assess if tofacitinib significantly reduced the Frontal Fibrosing Alopecia Severity Index (FFASI), Frontal Fibrosing Alopecia Severity Score (FFASS), and Lichen Planopillaris Activity Index (LPPAI) compared to baseline and after 16 weeks, and to evaluate adverse events.
Key results
The trial reported several median scores for the effectiveness of oral tofacitinib in recalcitrant frontal fibrosing alopecia:
- For the outcome "Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA)", one median score was 47.5 (Standard Deviation: 13.25) on a scale.
- Another median score for the same outcome was 44 (Standard Deviation: 13.5) on a scale.
- A further median score was 16.3 (Standard Deviation: 4.07) on a scale.
- Another median score was 15.9 (Standard Deviation: 4.62) on a scale.
- A median score of 1.83 (Standard Deviation: 1.01) on a scale was also reported.
- Lastly, a median score of 1.33 (Standard Deviation: 0.49) on a scale was reported.
Regarding the clinical and investigation safety of oral tofacitinib in recalcitrant FFA:
- 4 participants were reported for one safety outcome.
- 5 participants were reported for another safety outcome.
What this means
The posting of these trial results provides initial data on the use of tofacitinib in a pilot study for recalcitrant frontal fibrosing alopecia and lichen planopilaris of the scalp. The reported median scores for effectiveness and the number of participants related to safety outcomes offer preliminary insights into the drug's profile in this specific patient population. As a pilot study with a small enrollment of 11 participants, these findings contribute to the understanding of tofacitinib in these conditions, but further research would be needed to establish definitive efficacy and safety.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06202560, titled "Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study," were posted on 2025-05-30 on clinicaltrials.gov.