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

NCT06202560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-05-30

Study results available
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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.

Conditions

  • Frontal Fibrosing Alopecia
  • Lichen Planopilaris of Scalp

Interventions

DRUG

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.

Sponsors & Collaborators

  • Institute of Dermatology, Thailand

    lead OTHER_GOV

Principal Investigators

  • Chinmanat Lekhavat, MD · Institute of Dermatology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2024-07-10
Completion
2024-07-10

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06202560 on ClinicalTrials.gov