Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07545720

Pinoxin for the Prevention of Radiation-Induced Skin Injury

Led by Fudan University · Updated on 2026-04-22

202

Participants Needed

2

Research Sites

121 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pinoxin for the Prevention of Radiation-Induced Skin Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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.
Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

2

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

Z

Zhen Zhang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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