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

Sponsor
Institute of Dermatology, Thailand
Study ID
NCT06202560
Status
Completed

Conditions

  • Frontal Fibrosing Alopecia
  • Lichen Planopilaris of Scalp

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Nov 29, 2023
Status verified
May 2025
Primary completion
Jul 10, 2024
Completion
Jul 10, 2024

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib
    taking oral Tofacitinib 5 mg twice a day for 12 weeks

Primary Outcome Measure

Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) [ Time Frame: 16 weeks after taking oral Tofacitinib ]

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