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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs061180044
• Date of registration: 12/03/2019
• Prospective Registration: No
• Primary sponsor: Morita Eishin
• Public title: Multicenter Open-trial of Steroid pulse therapy for SJS/TEN
• Scientific title: Multicenter Open-trial of Steroid pulse therapy for SJS/TEN - MOSST Study
• Date of first enrolment: 01/06/2017
• Target sample size: 20
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs061180044
• Study type: Interventional
• Study design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
• Phase: 2

Countries of recruitment

Germany, Japan, Taiwan

Contacts

• Name: Eishin Morita
• Affiliation: Shimane University Hospital

• Name: Hiroyuki Niihara
• Affiliation: Shimane University Hospital

Key inclusion & exclusion criteria

Inclusion 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.
Exclusion 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.

Age minimum: >= 20age old
Age maximum: <= 90age old
Gender: Both

Health Condition(s) or Problem(s) studied

Stevens-Johnson syndrome and Toxic epidermal necrolysis

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.

Primary Outcome(s)

Effectiveness in Scoring for clinical evaluation on day7
(Effective: more than 6 point decrease)

Secondary Outcome(s)

Effectiveness in Scoring for clinical evaluation on day4, 10,
20, and end of the study

Secondary ID(s)

UMIN000028037

Source(s) of Monetary Support

Ministry of Health, Labour and Welfare

Ethics review

Status: Approval
Approval date: 25/12/2018
Contact:

[e-mail]

Shimane University Hospital, Clinical Trial Review Baord

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 31/12/2021
• Date Completed: 12/05/2020