Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Massachusetts General Hospital

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Drug Reaction

Interventions

Site specific standard of care comparisonDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mortality

Percent of deaths in each group

Time frame: 3 years

Time to cessation of new lesion formation

Days until no new lesions arise from time of initiation of therapy

Time frame: 3 years

Time to re-epithelialization

Days until skin has completely healed

Time frame: 3 years

Hospital length of stay

Time from hospital admission to discharge

Time frame: 3 years

Data from ClinicalTrials.gov

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