Clinical study on the efficacy and safety of Pi-Yan-Ning in the treatment of grade II-III maculopapular rash caused by immune checkpoint inhibitors

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200005924

Enrollment

Unknown

Registered

2022-04-27

Start date

2022-05-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rash caused by immune checkpoint inhibitors

Interventions

Positive control group:corticosteroide therapy was given according to CSCO guidelines

Pi-Yan-Ning group:Pi-Yan-Ning for external use, twice a day, 20min each time

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) =18 years old, males or females; (2) Receive ICIs treatment; (3) Confirmed by the joint consultation of oncologists and dermatologists or skin biopsy, diagnosed with grade II-III maculopapular rash according to the guideline of the management of immune checkpoint inhibitor-related toxicity formulated by CSCO; (4) The general condition is good, KPS>60, and the estimated survival time= 3 months; (5) The functional level of main organs should meet the following standards: ? Routine blood test: ANC=1.5×10^9/L; PLT=80×10^9/L; Hb=90g/L; ? Biochemical test: TBIL<1.5×ULN; ALT, AST<2.5×ULN (liver metastasis<5×ULN), BUN and Cr=1×ULN or Ccr=50ml/min (Cockcroft Gault formula); (6) Adhere to medication according to the doctor's advice, cooperate with follow-up, understand the situation of this study and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) The estimated survival time<3 months; (2) There are adverse reactions of other systems caused by ICIs, such as immune hepatitis, pneumonia, encephalitis, myocarditis, etc; (3) Exist the skin lesions or diseases affecting the study, or have a history of drug contact allergy; (4) Received corticosteroid or any other drugs that may affect ICIs-related maculopapular rash within 1 week before the start of the study, including proprietary Chinese medicine and herbal medicine; (5) Serious or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases); (6) Any unstable systemic disease (including active infection, grade 3 hypertension, unstable angina pectoris, congestive heart failure, liver, kidney or metabolic diseases); (7) Have a clear history of neurological or mental disorders, including epilepsy and dementia; (8) Pregnant or lactating patients; (9) The subject may not be able to complete the study or comply with the requirements of the study (due to management or other reasons).

Design outcomes

Primary

Measure	Time frame
Median time of disease remission;Drug efficiency;	—

Secondary

Measure	Time frame
??????;Recurrence rate;Drug safety;Quality of life;	—

Countries

China

Contacts

Public ContactQijin Shu

shuqjhz@163.com13605706566

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026