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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	17 April 2023
Main ID:	NCT03585946
Date of registration:	14/03/2018
Prospective Registration:	Yes
Primary sponsor:	Massachusetts General Hospital
Public title:	Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
Scientific title:	A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
Date of first enrolment:	January 1, 2024
Target sample size:	750
Recruitment status:	Not yet recruiting
URL:	https://clinicaltrials.gov/show/NCT03585946
Study type:	Observational
Study design:
Phase:

Countries of recruitment

Contacts

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stevens-Johnson Syndrome

Toxic Epidermal Necrolysis

Drug Reaction

Intervention(s)

Drug: Site specific standard of care comparison

Primary Outcome(s)

Hospital length of stay [Time Frame: 3 years]

Mortality [Time Frame: 3 years]

Time to cessation of new lesion formation [Time Frame: 3 years]

Time to re-epithelialization [Time Frame: 3 years]

Secondary Outcome(s)

Secondary ID(s)

P201700P002792

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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