Immune Checkpoint Inhibitor-related RashNCT07821424
Wucao Anfu Formula as Adjunctive Treatment for Immune Checkpoint Inhibitor-Related Rash
A study testing Wucao Anfu Formula and Standard management in people with Immune Checkpoint Inhibitor-related Rash and Immune-related Adverse Events, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Immune Checkpoint Inhibitor-related Rash, Immune-related Adverse Events
- What is being tested?
- Wucao Anfu Formula and Standard management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Being tested
- Wucao Anfu Formula, Standard management
- Keywords
- Wucao Anfu Formula, Traditional Chinese Medicine, Immune checkpoint inhibitor, Immune-related adverse event, Skin rash, External therapy
- Medical subject headings
- Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wucao Anfu FormulaOther
Also called 五草安肤方
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.
Standard managementOther
Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days after treatment initiation
Secondary outcomes (2)
Change in Rash Severity Grade
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.
Measured: Baseline and 14 days after treatment initiation
Treatment-related Adverse Events
Incidence and severity of adverse events during the study period.
Measured: Baseline to 14 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start5 Sep 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint Inhibitor-related RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kong Fanming, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821424
- Sponsor's protocol ID
- TYLL2026[Z]字 072
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No