Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

NCT03585946 — Withdrawn, Massachusetts General Hospital

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

Registry	NCT03585946
Status	Withdrawn - Change in study design
Study type	Observational
Sponsor	Massachusetts General Hospital (Other)
Conditions	Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Reaction
Interventions	Site specific standard of care comparison (Drug)
Dates	start 2030-01-01 (estimated), primary completion 2040-12-31 (estimated), completion 2040-12-31 (estimated), first posted 2018-07-13, last updated 2026-01-16

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Cyclosporine		Drug: Site specific standard of care comparison
Intravenous Immunoglobulin		Drug: Site specific standard of care comparison
Etanercept		Drug: Site specific standard of care comparison
Steroids		Drug: Site specific standard of care comparison

Site specific standard of care comparison (Drug): 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.

+Outcome measures

Primary outcomes

Mortality [3 years]: Percent of deaths in each group
Time to cessation of new lesion formation [3 years]: Days until no new lesions arise from time of initiation of therapy
Time to re-epithelialization [3 years]: Days until skin has completely healed
Hospital length of stay [3 years]: Time from hospital admission to discharge

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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