RecruitingPhase 2

Pinoxin for the Prevention of Radiation-Induced Skin Injury

China202 participantsStarted 2024-09-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years, regardless of gender.
✓. Pathologically diagnosed with a malignant tumor.
✓. Scheduled to receive long-course radiotherapy with a total dose of ≥50 Gy, in accordance with standard treatment guidelines.
✓. No prior history of radiotherapy.
✓. Has provided signed and dated informed consent, indicating that the patient has been informed of all relevant aspects of the study.
✓. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion criteria

✕. History of dermatologic conditions (e.g., vitiligo, psoriasis, etc.) or collagen vascular diseases.
✕. Planned hypofractionated radiotherapy regimen.
✕. Recent use (e.g., within 3 months) of similar topical protective agents.
✕. Known hypersensitivity to any related components or materials.
✕. Immunodeficiency disorders.
✕. Women who are pregnant or lactating.
✕. 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.

What they're measuring

adverse effect

Timeframe: from the start of radiotherapy to 3 months

≥ grade 2 acute skin injury

Timeframe: from the start of radiotherapy to 3 months

Trial details

NCT IDNCT07545720

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

Contact for this trial

Zhen Zhang, MD

+86-021-64175590 zhen_zhang@fudan.edu.cn

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