Stevens-Johnson SyndromeNCT03585946
Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
An observational study of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, run by Massachusetts General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Reaction
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2030to 31 Dec 2040
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Age <18y
- Decisional impairment
- Incarceration
- Onset of skin separation >7d
About this study
Official title: 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.
- Being tested
- Site specific standard of care comparison
- Medical subject headings
- Stevens-Johnson Syndrome, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Site specific standard of care comparisonDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine | Not described Receives: Drug: Site specific standard of care comparison | |
| Intravenous Immunoglobulin | Not described Receives: Drug: Site specific standard of care comparison | |
| Etanercept | Not described Receives: Drug: Site specific standard of care comparison | |
| Steroids | Not described Receives: Drug: Site specific standard of care comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Percent of deaths in each group
Measured: 3 years
Time to cessation of new lesion formation
Days until no new lesions arise from time of initiation of therapy
Measured: 3 years
Time to re-epithelialization
Days until skin has completely healed
Measured: 3 years
Hospital length of stay
Time from hospital admission to discharge
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start1 Jan 2030 (estimated)
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2040 (estimated)
Why it stopped: Change in study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stevens-Johnson SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Kroshinsky, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585946
- Sponsor's protocol ID
- P201700P002792
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2018
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
- ClinicalTrials.gov ID
- NCT03585946
- Acronym / sponsor ID
- P201700P002792
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change in study design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2030 (estimated)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy
- Age <18y
- Decisional impairment
- Incarceration
- Onset of skin separation >7d
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Site specific standard of care comparisonPatients 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. | Drug | Cyclosporine, Etanercept, Intravenous Immunoglobulin, Steroids |
Primary outcome
Mortality
Time frame: 3 years
Percent of deaths in each group
Time to cessation of new lesion formation
Time frame: 3 years
Days until no new lesions arise from time of initiation of therapy
Time to re-epithelialization
Time frame: 3 years
Days until skin has completely healed
Hospital length of stay
Time frame: 3 years
Time from hospital admission to discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.