Wucao Anfu Formula as Adjunctive Treatment for Immune Checkpoint Inhibitor-Related Rash
Study Overview
Status
Intervention / Treatment
Detailed Description
mmune checkpoint inhibitors (ICIs) have become important treatments for various malignant tumors. However, immune-related adverse events, especially skin toxicities such as rash and dermatitis, occur frequently during ICI therapy and may negatively affect patients' quality of life and anticancer treatment adherence. Current management strategies mainly include skin care, antihistamines, and topical corticosteroids. Evidence regarding the role of traditional Chinese medicine-based external therapy as an adjunctive intervention remains limited.
This study is a multicenter, randomized, parallel-controlled clinical trial designed to evaluate the efficacy and safety of Wucao Anfu Formula as an adjunctive treatment for ICI-related rash. A total of 72 eligible participants with grade 1-2 ICI-related inflammatory skin rash will be randomly assigned in a 1:1 ratio to the intervention group or control group.
Both groups will receive standardized skin care and topical corticosteroid treatment. Participants in the intervention group will additionally receive Wucao Anfu Formula external wet compress therapy twice daily for 14 days. The control group will receive standard topical corticosteroid treatment alone.
The primary outcome is the overall improvement rate of ICI-related rash at day 14 after treatment. Secondary outcomes include changes in rash severity according to Common Terminology Criteria for Adverse Events (CTCAE), rash-related clinical symptoms and signs, itching severity, skin dryness, dermatology-specific quality of life, performance status, rescue treatment use, and safety outcomes including adverse events and laboratory examinations.
The study will provide clinical evidence regarding whether Wucao Anfu Formula can improve ICI-related rash while maintaining safety, and may contribute to the development of integrative approaches for managing immune-related adverse events during cancer immunotherapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Patients aged 18 years or older. 2. Patients with malignant tumors treated with immune checkpoint inhibitors who developed immune checkpoint inhibitor-related rash.
3. Patients meeting the diagnostic criteria for immune checkpoint inhibitor-related rash.
4. Patients voluntarily participating in the study and providing written informed consent.
Exclusion Criteria:
1. Patients with severe uncontrolled systemic diseases or serious organ dysfunction.
2. Patients with other skin diseases that may affect evaluation of rash. 3. Patients allergic to any component of Wucao Anfu Formula. 4. Pregnant or breastfeeding women. 5. Patients unable to complete the treatment protocol or follow-up. 6. Patients who withdraw informed consent voluntarily.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Wucao Anfu Formula Group
Participants in this group will receive Wucao Anfu Formula external therapy in addition to standard management for immune checkpoint inhibitor-related rash.
|
Wucao Anfu Formula is an external traditional Chinese medicine therapy.
Participants in the intervention group will receive Wucao Anfu Formula external wet compress therapy in addition to standard management for immune checkpoint inhibitor-related rash.
The intervention will be administered for 14 days according to the study protocol.
Other Names:
Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
|
|
Active Comparator: Control Group
Participants in this group will receive standard management for immune checkpoint inhibitor-related rash without Wucao Anfu Formula therapy.
|
Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rash Response Rate
Time Frame: 14 days after treatment initiation
|
The proportion of participants achieving complete response or partial response of immune checkpoint inhibitor-related rash after treatment according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria.
|
14 days after treatment initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Rash Severity Grade
Time Frame: Baseline and 14 days after treatment initiation
|
Change in severity grade of immune checkpoint inhibitor-related rash assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria before and after treatment.
|
Baseline and 14 days after treatment initiation
|
|
Treatment-related Adverse Events
Time Frame: Baseline to 14 days after treatment initiation
|
Incidence and severity of adverse events during the study period.
|
Baseline to 14 days after treatment initiation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TYLL2026[Z]字 072
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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