Pinoxin to prevent radiation skin injury

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

See if spraying Pinoxin four times daily can prevent skin damage in adults receiving long-course radiotherapy (≥50 Gy) with radiation fields near the skin.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07545720 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-arm phase II trial enrolling 202 adult cancer patients who will receive radiotherapy of 50 Gy or higher with fields close to the skin. Participants are randomized 1:1 to receive either topical Pinoxin spray or a vitamin B12 placebo, applied four times daily from the start of radiotherapy until two weeks after completion. The primary outcome is the rate of grade 2 or greater radiation-induced skin injury; unblinding is allowed for grade 3 or higher reactions and placebo patients with severe injury may receive Pinoxin or other treatments. The design aims to show superior efficacy of Pinoxin compared with placebo in preventing clinically meaningful skin toxicity.

Who should consider this trial

Good fit: Adults (≥18) with a pathologic diagnosis of cancer scheduled for long-course radiotherapy ≥50 Gy with skin-near fields, no prior radiotherapy, able to follow study procedures, and who provide informed consent.

Not a fit: Patients receiving hypofractionated radiotherapy, those with preexisting dermatologic or collagen vascular diseases, immunodeficiency, or known hypersensitivity to study materials are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, Pinoxin could reduce moderate-to-severe radiation skin reactions, improving comfort and helping patients complete radiotherapy without interruptions.

How similar studies have performed: Topical protective agents for radiation dermatitis have shown mixed or limited success in prior work, and Pinoxin itself has not been tested widely in randomized trials.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Zhen Zhang, MD

Conditions Cancer Patients Undergoning Radiotherapy; radiation induced; radiationinduced