Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Not yet recruiting

• Conditions: Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis; Drug Reaction
• Interventions: Drug: Site specific standard of care comparison

• Registration Number: NCT03585946
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06
• Study Start: 2024-01-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Steroids	Site specific standard of care comparison	-
Etanercept	Site specific standard of care comparison	-
Cyclosporine	Site specific standard of care comparison	-
Intravenous Immunoglobulin	Site specific standard of care comparison	-

Primary Outcome Measures

Name	Time	Method
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