NCT03585946.

Study name	Outcomes in Stevens Johnsons syndrome and toxic epidermal necrolysis
Methods	Observational Model: cohort Time Perspective: prospective
Participants	750 participants 18 years of age and older   Sampling Method: non‐probability sample Study Population Adults hospitalised with a diagnosis of Stevens Johnson syndrome/toxic epidermal necrolysis confirmed by examination of a dermatologist and/or skin biopsy plus described appropriate clinical findings (epidermal necrosis plus 2 involved mucosal surfaces) presenting within 1 week of disease onset Criteria Inclusion Criteria: A diagnosis of Stevens Johnson syndrome/toxic epidermal necrolysis confirmed by examination of a dermatologist and/or skin biopsy plus described appropriate clinical findings (epidermal necrosis plus 2 involved mucosal surfaces) presenting within 1 week of disease onset Exclusion Criteria: Pregnancy Age < 18 years Decisional impairment Incarceration Onset of skin separation > 7 d
Interventions	Cyclosporin Intravenous Immunoglobulin Etanercept Steroids Drug: site‐specific standard‐of‐care comparison Patient 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.
Outcomes	Primary Outcome Measures Per cent of deaths in each group Days until no new lesions arise from time of initiation of therapy Days until skin has completely healed Time from hospital admission to discharge Mortality [ Time Frame: 3 years ] Time to cessation of new lesion formation [ Time Frame: 3 years ] Time to re‐epithelialisation [ Time Frame: 3 years ] Hospital length of stay [ Time Frame: 3 years ]
Starting date	1 September 2018
Contact information	Daniela Kroshinsky, Associate Professor of Dermatology, Massachusetts General Hospital
Notes	Estimated Study Completion Date: 31 August 2021

C0: conventionally measured trough level
C2: cyclosporin levels at 2 hours postdose
G‐CSF: granulocyte colony‐stimulating factor
IL‐15: interleukin‐15
SJS/TEN: Stevens‐Johnson syndrome/toxic epidermal necrolysis
WBC: white blood cell