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

SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) Versus Non-ICIs in Chinese Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06522048
Enrollment
300
Registered
2024-07-26
Start date
2015-01-31
Completion date
2024-05-31
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

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.

Interventions

OTHERObservational studies do not require intervention

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

Sponsors

Chao Ji
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Incomplete medical records * Unknown the specific culprit drugs

Design outcomes

Primary

MeasureTime frameDescription
Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors MedicationsJanuary 2015 to May 2024Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026