Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT06474078
Status
Completed

Conditions

  • Stevens-Johnson Syndrome
  • Toxic Epidermal Necrolysis

Eligibility Criteria

Sex
ALL
Age
20 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Dosage/Frequency: 5mg - 10mg, oral, twice daily

Study Details

The goal of this study is to evaluate the effect of tofacitinib in patients with Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The primary outcome of the study is the time to complete re-epithelialization. The secondary outcomes are to determine mortality, length of hospitalization, adverse events, the time to beginning of epithelization, the time to halting of progression of SJS/TEN, ocular complications, and infections.

Key Dates

Start date
Aug 1, 2022
Status verified
Aug 2025
Primary completion
Jun 20, 2025
Completion
Jun 20, 2025

Study Design

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

Arms

  • Experimental: Tofacitinib treatment
    1. Meet the conditions of inclusion and exclusion, seek the consent of the patient 2. Fill out the case report form 3. Blood test and physiological assessment, and do serum granulysin concentration and peripheral blood mononuclear spherical granulysin expression analysis 4. Tofacitinib administration: The experimental group received tofacitinib 5mg-10mg, twice daily, for the first week; and maintained tofacitinib 5mg-10mg, daily, for the second week.

Primary Outcome Measure

Complete Skin Healing Time, Day, Medium [Full Range] [ Time Frame: days ]

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