Grade 1-2 rash induced by EGFRIs
Conditions
Interventions
Test Group:For Grade 1 patients: Apply an appropriate amount of hydrocortisone cream placebo to cover the affected skin area, rub until absorbed, then apply an adequate amount of Pi-Yan-Ning and perfo
Control group:For Grade 1 patients: Apply an appropriate amount of hydrocortisone cream topically to cover the affected area. Rub until absorbed, then apply a suitable amount of Pi-Yan-Ning placebo fo
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Age = 18 years; 2.Patients with solid tumors receiving EGFRIs (Epidermal Growth Factor Receptor Inhibitors) treatment; 3.Meeting the diagnostic criteria for Grade 1-2 acneiform rash; 4.TCM (Traditional Chinese Medicine) syndrome pattern conforming to Dampness-Heat Syndrome (Shi-Re Zheng); 5.Good general condition with an ECOG (Eastern Cooperative Oncology Group) Performance Status score of 0-2 and a life expectancy = 3 months; 6.Voluntarily participating in this clinical study and providing informed consent prior to any study-specific procedures.
Exclusion criteria
Exclusion criteria: 1.Presence of other systemic skin disorders such as psoriasis eczema contact dermatitis etc.; 2.Had received medications for rash treatment (e.g. urea ointment corticosteroids antibiotics) within 1 week prior to study initiation; 3.Had used antihistamines to relieve itching caused by rash within 1 week prior to study initiation; 4.Dose reduction or temporary discontinuation of EGFR inhibitors (EGFRIs) therapy; 5.Occurrence of other grade 2 or higher adverse reactions related to anti-tumor treatment besides rash; 6.Patients deemed ineligible for participation by the investigator due to the presence of other conditions that may affect the clinical study process or outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skindex-16 score;Graded changes in associated symptoms (pruritus pain tightness);Safety;rash recurrence rate; | — |
Countries
China
Contacts
Public ContactQijin Shu
The First Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed