Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Stevens-Johnson Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03585946
• Other study ID #: P201700P002792
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Reaction
• Drug-Related Side Effects and Adverse Reactions
• Stevens-Johnson Syndrome
• Syndrome
• Toxic Epidermal Necrolysis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

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