EGFR inhibitor-related skin adverse reactions
Conditions
Interventions
Experimental Group:According to the standard of the Fingertip Unit (FTU), each patient will apply the 2% minocycline vaseline ointment to the lesions on one side of the body twice daily (once in the m
Control group (self control):Apply the corresponding area of the excipient matrix white Vaseline
Sponsors
Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older, male or female. 2. Diagnosis of visceral malignancy confirmed by pathology, currently receiving EGFR inhibitor therapy. 3. Voluntarily signs a written informed consent form to participate in the study, and is willing and able to comply with study-related visits and procedures. 4. Presence of EGFR inhibitor therapy-related rash rated as grade 2 or lower according to the Management of Epidermal Skin Toxicity Therapy Tool (MESTT) criteria. 5. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2. 6. Expected survival period >= 3 months. 7. Laboratory test results meeting the following requirements: (1) Aspartate aminotransferase (AST): = 75 × 10^9/L (without transfusion or apheresis platelets or growth factor use within 10 days prior to treatment initiation) (8) Absolute neutrophil count: >= 1.5 × 10^9/L (without growth factor use within 10 days prior to treatment initiation) (9) Hemoglobin > 90 g/L (without transfusion or growth factor use within 10 days prior to treatment initiation) (10) Coagulation parameter: INR 50 mL/min, calculated using the Cockcroft-Gault formula: (140 - Age [years]) × Weight (kg) × 1.23 × (0.85 if female) / Serum Creatinine (µmol/L) (13) Urea/urea nitrogen: <= 1.5 × ULN (14) Asymptomatic serum amylase = grade 2 (NCI-CTCAE v5.0). For patients with grade 2 serum amylase abnormality prior to the first dose, confirmation is required that there are no signs and/or symptoms suggestive of pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal pancreatic imaging findings, etc.). (15) Serum lipase <= 1.5 × ULN
Exclusion criteria
Exclusion criteria: 1. Systemic use of other antibiotics within 14 days prior to the study initiation or during the study period. 2. Use of any other topical medications during the study period, with the exception of moisturizers. 3. Patients with concurrent skin conditions that may affect efficacy evaluation (including but not limited to eczema and psoriasis). 4. At screening, the patient's ALT or AST is greater than or equal to 1.5 times ULN as defined by the center, or the endogenous CCr is greater than the ULN as defined by the center. 5. At screening, the patient's total white blood cell count (WBC) is greater than 10.0 × 10^9/L or less than 1.0 × 10^9/L. 6. Patient has a history of immunodeficiency diseases (e.g., HIV, etc.), autoimmune diseases, severe cardiovascular or cerebrovascular diseases, or other diseases that may significantly reduce life expectancy. 7. History of any condition that may affect protocol compliance (e.g., severe mental disorders, cognitive dysfunction, drug abuse or addiction, etc.). 8. Pregnant or breastfeeding women. 9. Men and women during the conception planning period (including those with explicit conception plans or not using effective contraception, and their partners). 10. Known allergy to any component of the study medication. 11. Patients judged by the investigator as unsuitable for participation in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| FACT-EGFR 18 score;FACT-EGFR 18 score;Lesion count;MESTT grade; | — |
Primary
| Measure | Time frame |
|---|---|
| Lesion count;MESTT grade; | — |
Countries
China
Contacts
Public ContactShen Zhu
Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
Outcome results
None listed