Brief Title
Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
Official Title
A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
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.
Study Type
Observational
Primary Outcome
Mortality
Condition
Stevens-Johnson Syndrome
Intervention
Site specific standard of care comparison
Study Arms / Comparison Groups
Cyclosporine
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
750
Start Date
January 1, 2021
Completion Date
December 31, 2021
Primary Completion Date
December 31, 2021
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Administrative Informations
NCT ID
NCT03585946
Organization ID
P201700P002792
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Study Sponsor
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Verification Date
December 2020