NCT03585946

Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stevens-Johnson Syndrome
• Toxic Epidermal Necrolysis
• Drug Reaction

Interventions

Type	Name	Description
DRUG	Site specific standard of care comparison	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.

Timeline

• Start date: 2030-01-01
• Primary completion: 2040-12-31
• Completion: 2040-12-31
• First posted: 2018-07-13
• Last updated: 2026-01-16

Regulatory

• FDA-regulated drug study