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Clinical Trials in China / NCT07545720
Recruiting Phase 2

Pinoxin for the Prevention of Radiation-Induced Skin Injury

NCT07545720 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 2
Started
2024-09-05
Last updated
2026-04-22

Condition(s) studied

Cancer Patients Undergoning Radiotherapy

Investigational drug(s) / intervention(s)

pinoxinPlacebo

pinoxin: Treatment group will receive prophylactic skin administration of Pinoxin,which is kind of Skin Protective Agent.

Placebo: Treatment group will receive prophylactic skin administration of placebo

Study summary

The incidence of radiation-induced skin injury is high, and effective preventive measures are currently lacking. This study evaluates the role of the skin protective agent Pinoxin in preventing skin injury. Patients are randomly assigned into two prospective groups: treatment group and control group. In treatment group, patients will receive Pinoxin treatment. In control group,patients will receive placebo treatment. The rate of grade 2 or greater skin injury will be analyzed.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years, regardless of gender. 2. Pathologically diagnosed with a malignant tumor. 3. Scheduled to receive long-course radiotherapy with a total dose of ≥50 Gy, in accordance with standard treatment guidelines. 4. No prior history of radiotherapy. 5. Has provided signed and dated informed consent, indicating that the patient has been informed of all relevant aspects of the study. 6. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. History of dermatologic conditions (e.g., vitiligo, psoriasis, etc.) or collagen vascular diseases. 2. Planned hypofractionated radiotherapy regimen. 3. Recent use (e.g., within 3 months) of similar topical protective agents. 4. Known hypersensitivity to any related components or materials. 5. Immunodeficiency disorders. 6. Women who are pregnant or lactating. 7. Any other condition that, in the investigator's judgment, may compromise patient safety or protocol compliance. This includes severe concomitant illnesses (including psychiatric disorders) requiring active treatment, significant laboratory abnormalities, or significant social/familial factors.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Fudan University Shanghai Cancer Center Shanghai China Recruiting

More Fudan University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07545720 on ClinicalTrials.gov ↗ ← All trials in China