Status:
RECRUITING
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis
Lead Sponsor:
Peng Zhang
Conditions:
Toxic Epidermal Necrolysis
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis
Eligibility Criteria
Inclusion
- Age 18 and above.
- Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria.
- Liver and kidney function is within acceptable ranges.
- Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges.
- Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.
- Patients need to be capable of participating in follow-up visits and treatment plans.
Exclusion
- History of allergy to JAK inhibitors.
- Pregnant or breastfeeding women.
- Severe infectious conditions.
- History of central nervous system demyelinating diseases.
- History of lymphoproliferative diseases.
- Active and latent tuberculosis.
- HIV carriers with a CD4+ T cell count lower than (\<200/mL).
- Active HBV/HCV infection.
- Coagulation disorders or a tendency for thrombosis.
- Significant abnormalities in blood routine indicators.
- Liver or kidney dysfunction.
Key Trial Info
Start Date :
July 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06119490
Start Date
July 5 2023
End Date
September 1 2026
Last Update
November 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.
Fuzhou, Fujian, China, 350000