Pinoxin for the Prevention of Radiation-Induced Skin Injury

Официальное название

A Multicenter, Randomized, Controlled, Double-Blind Clinical Study of Hydrogen-Donor Modified SOD (Pinoxin) for the Prevention of Radiation-Induced Skin Injury

Обзор

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.

Подробное описание

This study is a prospective, randomized controlled, multicenter phase II study, with a design of superior efficacy，to compare the efficacy of Pinoxin and placebo in protecting radiation induced skin injury. We will consecutively enrolled patients who were diagnosed with cancer，and will receive radiotherapy at the dose of 50Gy or higher and radiation field is near skin. A total of 202 patients will be Randomized 1:1 to the treatment group and control group. In treatment group, patients will be sprayed Pinoxin，four times daily (morning, noon, evening, bedtime) from radiotherapy start until 2 weeks post-radiotherapy (continuous, including weekends) .In control group, patiants will received vitamin B12 as placebo. The dosing frequency is the same as that in the treatment group. Unblinding will be triggered if Grade 3 or higher reactions occur. If participants in the placebo control group develop Grade 3 or higher skin injury, they are permitted to use Pinoxin or opt for other appropriate symptomatic treatments.

Вмешательства

• Препарат pinoxin
  Treatment group will receive prophylactic skin administration of Pinoxin，which is kind of Skin Protective Agent.
• Препарат Placebo
  Treatment group will receive prophylactic skin administration of placebo

Первичные конечные точки

• adverse effect [Срок оценки: from the start of radiotherapy to 3 months]
• ≥ grade 2 acute skin injury [Срок оценки: from the start of radiotherapy to 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 2 центра

• Fudan University Shanghai Cancer Center — Шанхай
• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07545720 · P-RIDermatitis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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