Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

NCT ID: NCT03585946

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2030-01-01
• Study Completion Date: 2040-12-31

Brief Summary

This is a prospective, multicenter cohort observational; study to compare treatment outcomes in patients admitted to the hospital with Stevens-Johnsons Syndrome/Toxic Epidermolysis, aiming to assess the utility of medical management. The hypothesis of this study is that one or more treatment options will demonstrate improved patient outcomes. The primary objectives are cessation of progression of disease, time to complete re-epithelialization, length of stay, and mortality rate in the treatment groups as compared to those receiving supportive care alone. Exploratory analyses will assess the cause, risk factors, and severity prediction factors associated with the disease.

Conditions

Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis; Drug Reaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cyclosporine

Site specific standard of care comparison

Intervention Type: DRUG

Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.

Intravenous Immunoglobulin

Site specific standard of care comparison

Intervention Type: DRUG

Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.

Etanercept

Site specific standard of care comparison

Intervention Type: DRUG

Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.

Steroids

Site specific standard of care comparison

Intervention Type: DRUG

Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.

Interventions

Site specific standard of care comparison

Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• a diagnosis of Stevens Johnsons Syndrome/Toxic Epidermal Necrolysis confirmed by examination of a dermatologist and/or skin biopsy plus described appropriate clinical findings (epidermal necrosis plus two involved mucosal surfaces) presenting within one week of disease onset

Exclusion Criteria

• Pregnancy
• Age <18y
• Decisional impairment
• Incarceration
• Onset of skin separation >7d

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daniela Kroshinsky

Associate Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P201700P002792

Identifier Type: -

Identifier Source: org_study_id