About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of allergy to JAK inhibitors.
Pregnant or breastfeeding women.
Severe infectious conditions.
History of central nervous system demyelinating diseases.
Trial design
Parallel
Treatments tested in this trial
Abrocitinib
DrugSolu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks
Tofacitinib
DrugSolu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks
Treatment groups
Trial outcomes
Primary outcomes
Time to Reepithelization
duration from initiation of treatment to the point when skin detachment and erosions were no longer observed (negative Nikolsky's sign). Meanwhile, skin islands started to regenerate and replace the damaged superficial epithelia in local skin or mucous lesions (approximately 20% of the maximum BSA).
Secondary outcomes
Adverse events
The common adverse effects associated with treatments including elevated blood pressure, elevated blood glucose, gastrointestinal bleeding, electrolyte disturbance, and mucocutaneous infections were closely monitored during their hospitalization. All patients in both groups were followed up for 4 weeks to monitor the associated adverse effects.
Sponsors and contacts
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Peng Zhang
Lead sponsor
Fujian Provincial Hospital
Sponsor institution