Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

NCT03585946 | Withdrawn FDA Drug

• 1 other identifier: P201700P002792
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis; Drug Reaction

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

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

Interventions

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.

Cyclosporine; Etanercept; Intravenous Immunoglobulin; Steroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Age \<18y
• Decisional impairment
• Incarceration
• Onset of skin separation \>7d

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: July 13, 2018
• Study Start (Estimated): January 1, 2030
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR