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CompletedNCT06522048Updated Jul 29, 2024

SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) vs. Non-ICIs

An observational study in Immune Checkpoint Inhibitor-Induced Dermatitis, Stevens-Johnson Syndrome, Drug-Induced and Toxic Epidermal Necrolysis Due to Drug, sponsored by Chao Ji. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Chao Ji · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
300
Sex
All
01

Study summary

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction, characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs), versus other types of drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.

Read the detailed description

Introduction:

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs) versus other type drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.

Methods:

  • Study Design: Retrospective cohort study or cross-sectional study.
  • Participants: 60 patients with ICI-induced SJS/TEN and 100 to 500 patients with other drug-induced SJS/TEN.
  • Data Collection: Detailed medical records were reviewed to extract information.
  • Statistical Analysis: analysis using appropriate statistical tests (e.g., t-test, chi-square test).

Results:

Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.

Conclusion:

We discuss the clinical implications of the findings, potential mechanisms underlying the observed differences, and the relevance to patient management. Summarize the main findings and their significance for clinical practice. Emphasize the need for tailored treatment approaches based on the type of drug causing SJS/TEN.

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Conditions studied

  • Immune Checkpoint Inhibitor-Induced Dermatitis
  • Stevens-Johnson Syndrome, Drug-Induced
  • Toxic Epidermal Necrolysis Due to Drug
03

In context

Stevens-Johnson Syndrome

40 studies on the registry are indexed under Stevens-Johnson Syndrome; 8 are open to participants now.

Browse Stevens-Johnson Syndrome studies →

Lead sponsor

Chao Ji is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Detailed patient records for SJS/TEN were available in the dermatology inpatient department according to inclusion criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of SJS/TEN induced by any drugs
  • Have the immune-related cutaneous adverse events

Exclusion criteria

Exclusion Criteria:

  • Incomplete medical records
  • Unknown the specific culprit drugs
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
300 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Non-immune checkpoint inhibitor (non-ICI) drugs group

    Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by non-immune checkpoint inhibitor (non-ICI) drugs

    Other: Observational studies do not require intervention

  • Immune checkpoint inhibitor (ICIs) group

    Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by immune checkpoint inhibitor (ICIs)

    Other: Observational studies do not require intervention

Interventions

  • OtherObservational studies do not require intervention

    This is an observational retrospective study and does not require any intervention.

06

What researchers measure

Primary outcomes

  1. Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications

    Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.

    Time frame: January 2015 to May 2024

07

Study locations

1 site
  • First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian 350000, China
08

References and documents

Publications

  • Gerull R, Nelle M, Schaible T. Toxic epidermal necrolysis and Stevens-Johnson syndrome: a review. Crit Care Med. 2011 Jun;39(6):1521-32. doi: 10.1097/CCM.0b013e31821201ed. PubMed 21358399 ↗
  • Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA; National Comprehensive Cancer Network. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018 Jun 10;36(17):1714-1768. doi: 10.1200/JCO.2017.77.6385. Epub 2018 Feb 14. PubMed 29442540 ↗
  • Zimmermann S, Sekula P, Venhoff M, Motschall E, Knaus J, Schumacher M, Mockenhaupt M. Systemic Immunomodulating Therapies for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Systematic Review and Meta-analysis. JAMA Dermatol. 2017 Jun 1;153(6):514-522. doi: 10.1001/jamadermatol.2016.5668. PubMed 28329382 ↗
  • Van Wilpe S, Koornstra R, Den Brok M, De Groot JW, Blank C, De Vries J, Gerritsen W, Mehra N. Lactate dehydrogenase: a marker of diminished antitumor immunity. Oncoimmunology. 2020 Feb 26;9(1):1731942. doi: 10.1080/2162402X.2020.1731942. eCollection 2020. PubMed 32158624 ↗
  • Lin CC, Chen CB, Wang CW, Hung SI, Chung WH. Stevens-Johnson syndrome and toxic epidermal necrolysis: risk factors, causality assessment and potential prevention strategies. Expert Rev Clin Immunol. 2020 Apr;16(4):373-387. doi: 10.1080/1744666X.2020.1740591. Epub 2020 Apr 2. PubMed 32154748 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06522048
Lead sponsor
Chao Ji
Responsible party
Chao Ji (Vice President of the Dermatology Branch of the First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Fujian Medical University) — Sponsor-investigator
First posted
Jul 26, 2024
Start date
Jan 2015
Primary completion
May 2024
Completion
May 2024
Last update
Jul 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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