Wucao Anfu Formula as Adjunctive Treatment for Immune Checkpoint Inhibitor-Related Rash

NCT07821424 | Not Yet Recruiting

• 1 other identifier: TYLL2026[Z]字 072
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Immune checkpoint inhibitors have improved outcomes for patients with cancer, but immune checkpoint inhibitor-related skin rash is a common adverse event that may affect quality of life and continuation of anticancer therapy. This study aims to evaluate the efficacy and safety of Wucao Anfu Formula as an adjunctive treatment for immune checkpoint inhibitor-related rash. In this randomized controlled clinical study, eligible patients with grade 1-2 immune checkpoint inhibitor-related rash will be randomly assigned to receive standard topical corticosteroid treatment with or without Wucao Anfu Formula. The study will assess improvement of skin rash severity, symptoms, quality of life, and safety outcomes. The results may provide clinical evidence for integrative management of immune checkpoint inhibitor-related skin adverse events.

Conditions

Immune-related Adverse Events; Immune Checkpoint Inhibitor-related Rash

Keywords

Wucao Anfu Formula; Traditional Chinese Medicine; Immune checkpoint inhibitor; Immune-related adverse event; Skin rash; External therapy

Outcome Measures

Primary Outcomes (1)

• Rash Response Rate

  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 Outcomes (2)

• Change in Rash Severity Grade

  Baseline and 14 days after treatment initiation

• Treatment-related Adverse Events

  Baseline to 14 days after treatment initiation

Study Arms (2)

Wucao Anfu Formula Group

EXPERIMENTAL

Participants in this group will receive Wucao Anfu Formula external therapy in addition to standard management for immune checkpoint inhibitor-related rash.

Other: Wucao Anfu Formula; Other: Standard management

Control Group

ACTIVE COMPARATOR

Participants in this group will receive standard management for immune checkpoint inhibitor-related rash without Wucao Anfu Formula therapy.

Other: Standard management

Interventions

Wucao Anfu Formula OTHER

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.

Also known as: 五草安肤方

Wucao Anfu Formula Group

Standard management OTHER

Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.

Control Group; Wucao Anfu Formula Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients aged 18 years or older. 2. Patients with malignant tumors treated with immune checkpoint inhibitors who developed immune checkpoint inhibitor-related rash.
• \. Patients meeting the diagnostic criteria for immune checkpoint inhibitor-related rash.
• \. Patients voluntarily participating in the study and providing written informed consent.

You may not qualify if:

• \. Patients with severe uncontrolled systemic diseases or serious organ dysfunction.
• \. 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.

Sponsors & Collaborators

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Exanthema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the treatment allocation. Participants and care providers will not be blinded because the intervention involves external application of Wucao Anfu Formula. The investigators responsible for intervention administration will know the group allocation, but they will not participate in outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Both groups will receive standardized skin care and topical corticosteroid treatment. The intervention group will additionally receive Wucao Anfu Formula external wet compress therapy for 14 days.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-08