JRCT ID: jRCTs061180044
Registered date:12/03/2019
Multicenter Open-trial of Steroid pulse therapy for SJS/TEN
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Stevens-Johnson syndrome and Toxic epidermal necrolysis |
Date of first enrollment | 01/06/2017 |
Target sample size | 20 |
Countries of recruitment | Taiwan,Japan,Germany,Japan |
Study type | Interventional |
Intervention(s) | 1. infusion of methylprednisolone at 500~1000 mg/d (0.9% N/S in 3 hour) for 3 consecutive days. 2. Oral predonisolone (0.5 mg/kg/d) was initiated on the day following the last dose of methylprednisolone, and prednisolone was subsequently tapered within 2 weeks. If the ocular involvement score is more than 2, dose of oral predonisolone (1 mg/kg/d) is recommended. |
Outcome(s)
Primary Outcome | Effectiveness in Scoring for clinical evaluation on day7 (Effective: more than 6 point decrease) |
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Secondary Outcome | Effectiveness in Scoring for clinical evaluation on day4, 10, 20, and end of the study |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 90age old |
Gender | Both |
Include criteria | 1. The diagnosis of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) is given according to the guideline for the treatment of severe erythema exudativum multiforme. 2. SJS/TEN with epidermal detachment at least 1% BSA. 3. Patients above 20-years old and below 90 years old. 4. The onset of the disease (blistering) is less than 3 days (including) before inclusion. 5. Progression of the disease in the last 24 hrs, or no sign for improvement: new blisters or erythema on areas of previously uninvolved skin/ mucosae. 6. After reading or being informed on the Informed Consent Form and signing it, the subject or his deputy is willing and able to participate in the study. |
Exclude criteria | 1. The subject has received any systemic immunosuppressants or immunomodulating agents (continuously) for at least 3 days within 7 days preceding inclusion. (Systemic immunosuppressants or immunomodulating agents include azathioprine, corticosteroids*, cyclophosphamide, cyclosporine, immunoglobulins, plasmapheresis, etc.) *predonisolone dose of more than 0.5 mg/kg 2. The subject is in the situation of pregnancy or breastfeeding. 3. The subject has previous allergy to glucocorticosteroid or preservatives. 4. The subject has active, untreated or uncontrolled severe infectious, or septicaemia 5. The subject has any severe, life threatening cardiac arrhythmia e.g. ventricular tachycardia, recent myocardial infarction within 6 weeks, uncontrolled severe hypertension, or any severe cardiac disease according to a consulted cardiologist. 6. The subject has active gastrointestinal bleeding, acute gastric ulcer, intestinal perforation. 7. The subject has uncontrolled severe diabetes mellitus. 8. The subject has past history of avascular necrosis. 9. The subject having active viral hepatitis. 10. The subject is HBV carrier (HBsAg+), or untreated latent tubercurosis. 11. The subject under hemodialysis. 12. The subject with SJS/TEN overlapping of DIHS/DRESS. 13. The subject has any concomitant illness, which, in the opinion of the investigator, will interfere with the evaluation of the study medication or presents a contraindication for steroid pulse therapy. |
Related Information
Primary Sponsor | Morita Eishin |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
Secondary ID(s) | UMIN000028037 |
Contact
Public contact | |
Name | Hiroyuki Niihara |
Address | 89-1, Enya-cho, Izumo-shi, Shimane Shimane Japan 693-8501 |
Telephone | +81-853-20-2211 |
ofcourse@med.shimane-u.ac.jp | |
Affiliation | Shimane University Hospital |
Scientific contact | |
Name | Eishin Morita |
Address | 89-1, Enya-cho, Izumo-shi, Shimane Shimane Japan 693-8501 |
Telephone | +81-853-20-2210 |
emorita@med.shimane-u.ac.jp | |
Affiliation | Shimane University Hospital |