NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180044

Registered date:12/03/2019

Multicenter Open-trial of Steroid pulse therapy for SJS/TEN

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedStevens-Johnson syndrome and Toxic epidermal necrolysis
Date of first enrollment01/06/2017
Target sample size20
Countries of recruitmentTaiwan,Japan,Germany,Japan
Study typeInterventional
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 OutcomeEffectiveness in Scoring for clinical evaluation on day7 (Effective: more than 6 point decrease)
Secondary OutcomeEffectiveness in Scoring for clinical evaluation on day4, 10, 20, and end of the study

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 90age old
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Hiroyuki Niihara
Address 89-1, Enya-cho, Izumo-shi, Shimane Shimane Japan 693-8501
Telephone +81-853-20-2211
E-mail 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
E-mail emorita@med.shimane-u.ac.jp
Affiliation Shimane University Hospital