An Open-Label Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of Tofacitinib in Patients With Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 90
Healthy Volunteers: f
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• Willing to sign inform consent form
• Subject has been diagnosed with Stevens-Johnson syndrome or toxic epidermal necrolysis by at least two dermatologists.
• Male or female aged over 20 years old and under 90 years old.
Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital
Taoyuan District
Time Frame
Start Date: 2022-08-01
Completion Date: 2025-06-20
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital