Tofacitinib versus methotrexate for nail lichen planus and trachyonychia

Randomised comparative trial comparing oral tofacitinib with oral methotrexate in nail lichen planus and trachyonychia: an investigator blinded trial. - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100051

Enrollment

Registered

2026-01-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L438- Other lichen planus

Interventions

Intervention1: Oral tofacitinib in nail lichen planus and trachyonychia: Oral tofacitinib in nail lichen planus and trachyonychia, for more than 40 kg- 5mg twice daily, for 20 to 40kg- 2.5mg twice dai

for 6 months Control Intervention1: Oral methotrexate in nail lichen planus and trachyonychia: Oral methotrexate in nail lichen planus and trachyonychia, 0.3mg/kg/week for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with nail lichen planus/ trachyonychia (with at least one nail involved) established based on typical clinical findings with or without nail biopsy. 2. Age 12 to 60 years 3. Both treatment na ve patients and those experiencing relapse will be included in the study.

Exclusion criteria

Exclusion criteria: 1. Presence of any contraindications for tofacitinib/ methotrexate s use 2. Females of reproductive age group who have not completed their family or are not willing to use contraception as required. 3. Patients on any other immunosuppressive, immunomodulatory drugs or on drugs that has significant interaction with methotrexate/ tofacitinib. 4. Patients who are unable to attend proposed regular follow-up visits.

Design outcomes

Primary

Measure	Time frame
The proportion of patients with nail lichen planus and trachyonychia achieving 50% improvement in PGA at 24 weeks in patients receiving oral tofacitinib vis-a-vis oral methotrexate.Timepoint: The proportion of patients with nail lichen planus and trachyonychia achieving 50% improvement in PGA at 24 weeks in patients receiving oral tofacitinib vis-a-vis oral methotrexate.	—

Secondary

Measure	Time frame
1) The proportion of patients with nail lichen planus achieving 50% improvement in tNLPSI at 24 weeks in patients receiving oral tofacitinib vis-a-vis oral methotrexate. 2) To evaluate improvement in the quality of life. 3) To document the dermoscopic feature of nail lichen planus & trachyonychia at baseline & to document sequential change with treatment. 4) To evaluate the adverse effects of oral tofacitinib & oral methotrexate.Timepoint: baseline, 4 weeks, 8 weeks, 16 weeks, 24 weeks	—

Measure

Time frame

1) The proportion of patients with nail lichen planus achieving 50% improvement in tNLPSI at 24 weeks in patients receiving oral tofacitinib vis-a-vis oral methotrexate. 2) To evaluate improvement in the quality of life. 3) To document the dermoscopic feature of nail lichen planus & trachyonychia at baseline & to document sequential change with treatment. 4) To evaluate the adverse effects of oral tofacitinib & oral methotrexate.Timepoint: baseline, 4 weeks, 8 weeks, 16 weeks, 24 weeks

—

Countries

India

Contacts

Public ContactMadhav Verma

PGIMER CHANDIGARH

vinay.keshavmurthy@gmail.com8872993222

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026