Wucao Anfu Formula as Adjunctive Treatment for Immune Checkpoint Inhibitor-Related Rash
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
Andere Namen:
Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rash Response Rate
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Rash Severity Grade
Zeitfenster: 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
Zeitfenster: Baseline to 14 days after treatment initiation
|
Incidence and severity of adverse events during the study period.
|
Baseline to 14 days after treatment initiation
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- TYLL2026[Z]字 072
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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