Skip to main content
Clinical Trials/NCT03585946
NCT03585946
Withdrawn
N/A

A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Massachusetts General Hospital0 sites750 target enrollmentJanuary 1, 2030

Overview

Phase
N/A
Intervention
Site specific standard of care comparison
Conditions
Stevens-Johnson Syndrome
Sponsor
Massachusetts General Hospital
Enrollment
750
Primary Endpoint
Time to re-epithelialization
Status
Withdrawn
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2030
End Date
December 31, 2040
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniela Kroshinsky

Associate Professor of Dermatology

Massachusetts General Hospital

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

Arms & Interventions

Cyclosporine

Intervention: Site specific standard of care comparison

Intravenous Immunoglobulin

Intervention: Site specific standard of care comparison

Etanercept

Intervention: Site specific standard of care comparison

Steroids

Intervention: Site specific standard of care comparison

Outcomes

Primary Outcomes

Time to re-epithelialization

Time Frame: 3 years

Days until skin has completely healed

Hospital length of stay

Time Frame: 3 years

Time from hospital admission to discharge

Mortality

Time Frame: 3 years

Percent of deaths in each group

Time to cessation of new lesion formation

Time Frame: 3 years

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

Similar Trials