A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
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- Withdrawn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.
Investigators
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