Unique ID issued by UMIN | UMIN000028037 |
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Receipt number | R000032024 |
Scientific Title | Multicenter Open-trial of Steroid pulse therapy for SJS/TEN |
Date of disclosure of the study information | 2017/07/06 |
Last modified on | 2021/07/05 08:45:46 |
Multicenter Open-trial of Steroid pulse therapy for SJS/TEN
MOSST Study
Multicenter Open-trial of Steroid pulse therapy for SJS/TEN
MOSST Study
Japan | Asia(except Japan) | Europe |
SJS/TEN
Dermatology |
Others
NO
To evaluate efficacy and safety of multicenter open-trial of Steroid pulse therapy for SJS/TEN in acute stage
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
Scoring clinical evaluations; skin involvement, lip/oral mucosa involvement, eye involvement, general findings
Vital sign
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Medicine |
Initiation of steroid pulse therapy within 3 days from onset
20 | years-old | <= |
90 | years-old | >= |
Male and Female
1.Cases with definite diagnosis of SJS/TEN
2.Blister or epidermolysis area with more
than 1% of body surface area
3.New formation of blister or erythema
4.Obtaining informed consent
5.Within 3 days from onset
1.Medication of Immunosuppressive or
Immunomodulatory drugs for more than 3 days within 7days from onset or Immunosuppressive such as plasmapheresis
2.History of allergy to preservative products in adrenal cortical steroid
4.Affected severe sepsis
5.Affected severe cardiac disease
6.Active gastric ulceror bleeding
7.Uncontrolled DM
8.History of leg gangrene
9.active virus disease
10.Hepatitis B virus carrier
11.Untreated tuberculosis
12.Hemodialysis
13.Complicating drug-induced hypersensitivity syndrome
14.Decision by primary doctor
20
1st name | Eishin |
Middle name | |
Last name | Morita |
Faculty of Medicine SHIMANE University
Dermatology
6938501
89-1 Enya-cho, Izumo, 693-8501, Shimane, Japan
0853-20-2210
emorita@med.shimane-u.ac.jp
1st name | Hiroyuki |
Middle name | |
Last name | Niihara |
Faculty of Medicine SHIMANE University
Dermatology
693-8501
89-1 Enya-cho, Izumo, 693-8501, Shimane, Japan
0853-20-2210
ofcourse@med.shimane-u.ac.jp
Faculty of Medicine SHIMANE University
Health and Labour Sciences Research Grants (Research on Intractable Diseases) from the Ministry of Health, Labour and Welfare of Japan.
Other
0
Shimane University Faculty of Medicine, IRB
89-1 Enya-cho, Izumo, 693-8501, Shimane, Japan
0853-20-2259
ytomii@med.shimane-u.ac.jp
NO
2017 | Year | 07 | Month | 06 | Day |
Unpublished
Preinitiation
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 07 | Month | 06 | Day |
2021 | Year | 03 | Month | 31 | Day |
2017 | Year | 07 | Month | 01 | Day |
2021 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032024
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