Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

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

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 Overview

• Status: Withdrawn
• Conditions: Stevens-Johnson Syndrome; Drug Reaction; Toxic Epidermal Necrolysis
• Intervention / Treatment: Drug: Site specific standard of care comparison

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults hospitalized with 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cyclosporine	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.
Intravenous Immunoglobulin	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.
Etanercept	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.
Steroids	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2030
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Immune System Diseases; Hypersensitivity; Chemically-Induced Disorders; Skin Diseases; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Dermatitis; Erythema; Drug Eruptions; Drug Hypersensitivity; Stomatitis; Erythema Multiforme; Skin and Connective Tissue Diseases; Drug-Related Side Effects and Adverse Reactions; Stevens-Johnson Syndrome
• Other Study ID Numbers: P201700P002792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data to be recorded includes age, gender, past medical history, medications prior to admission, allergies, physical exam including body sites and surface area involved, pain scores, laboratory values, imaging results, and outcome in terms of morbidity and mortality. The privacy of subjects and their data will be maintained by de-identifying patient data by substituting codes for medical record numbers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes