Last updated: November 22, 2023
Sponsor: Peng Zhang
Overall Status: Active - Recruiting
Phase
1
Condition
Rash
Urticaria
Dry Eye Disease
Treatment
Tofacitinib
Abrocitinib
Clinical Study ID
NCT06119490
IECFOM-2023-400
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 plateletcount, are within acceptable ranges.
- Patients must sign an informed consent form, understanding the risks and potentialbenefits of the treatment.
- Patients need to be capable of participating in follow-up visits and treatment plans.
Exclusion
Exclusion Criteria:
- 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.
Study Design
Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Tofacitinib
Phase: 1
Study Start date:
July 05, 2023
Estimated Completion Date:
September 30, 2026
Connect with a study center
Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.
Fuzhou, Fujian 350000
ChinaActive - Recruiting

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