Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

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Brief Title

Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

Mortality


Condition

Stevens-Johnson Syndrome

Intervention

Site specific standard of care comparison

Study Arms / Comparison Groups

 Cyclosporine
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

750

Start Date

January 1, 2021

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 



Administrative Informations


NCT ID

NCT03585946

Organization ID

P201700P002792


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital


Study Sponsor

, , 


Verification Date

December 2020