---
title: SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) vs. Non-ICIs
nct_id: NCT06522048
overall_status: COMPLETED
sponsor: Chao Ji
study_type: OBSERVATIONAL
primary_condition: Immune Checkpoint Inhibitor-Induced Dermatitis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06522048.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06522048"
ct_last_update_post_date: 2024-07-29
last_seen_at: "2026-05-12T06:44:20.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) vs. Non-ICIs

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

**NCT ID:** [NCT06522048](https://clinicaltrials.gov/study/NCT06522048)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 300
- **Lead Sponsor:** Chao Ji
- **Conditions:** Immune Checkpoint Inhibitor-Induced Dermatitis, Stevens-Johnson Syndrome, Drug-Induced, Toxic Epidermal Necrolysis Due to Drug
- **Start Date:** 2015-01
- **Completion Date:** 2024-05
- **CT.gov Last Update:** 2024-07-29

## 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.

## Eligibility

- **Sex:** 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
```

## Arms

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

## Interventions

- **Observational studies do not require intervention** (OTHER) — This is an observational retrospective study and does not require any intervention.

## Primary Outcomes

- **Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications** _(time frame: January 2015 to May 2024)_ — Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.

## Locations (1)

- First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.first affiliated hospital of fujian medical university|fuzhou|fujian|china` — added _(2026-05-12)_

---

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