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To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arocitinib-arm | Other | Evaluation of the efficacy and safety of methylprednisolone combined with abrocitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with Arocitinib 200 mg daily. |
|
| Tofacitinib-arm | Other | Evaluation of the efficacy and safety of methylprednisolone combined with tofacitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with tofacitinib 10 mg daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abrocitinib | Drug | Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Ji | Contact | +86 18651619908 | jichaofy@fjmu.edu.cn | |
| Peng Zhang | Contact | +86 13645096437 | 396159837@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, the First Affiliated Hospital of Fujian Medical University. | Recruiting | Fuzhou | Fujian | 350000 | China |
The results will be published in a peer-reviewed scientific paper and the data sets analyzed in this study can be obtained from the first author.
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| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
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| ID | Term |
|---|---|
| C000634427 | abrocitinib |
| D008776 | Methylprednisolone Hemisuccinate |
| C479163 | tofacitinib |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| Tofacitinib | Drug | Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks |
|
|
| D003872 |
| Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |