Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Mass General Brigham

Status: Not yet enrolling

Conditions: Drug Reaction; Toxic Epidermal Necrolysis; Stevens-Johnson Syndrome

Treatments: Drug: Site specific standard of care comparison

Study type: Observational

Funder types: Other

Identifiers

NCT03585946

P201700P002792

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

750 participants in 4 patient groups

Cyclosporine

Treatment:

Drug: Site specific standard of care comparison

Intravenous Immunoglobulin

Treatment:

Drug: Site specific standard of care comparison

Etanercept

Treatment:

Drug: Site specific standard of care comparison

Steroids

Treatment:

Drug: Site specific standard of care comparison