Pinoxin for the Prevention of Radiation-Induced Skin Injury

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Patients Undergoning Radiotherapy
• Intervention / Treatment: Drug: pinoxin; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 202
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhen Zhang, MD; Phone Number: +86-021-64175590; Email: zhen_zhang@fudan.edu.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Zhen Zhang, MD; Phone Number: +86-021-64175590; Email: zhen_zhang@fudan.edu.cn
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Principal Investigator: Zhen Zhang, MD
      • Contact: Zhen Zhang; Phone Number: +86-021-64175590; Email: zhen_zhang@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; Receiving prophylactic skin administration of Pinoxin.	Drug: pinoxin; Treatment group will receive prophylactic skin administration of Pinoxin，which is kind of Skin Protective Agent.
Placebo Comparator: control; Receiving prophylactic skin administration of placebo.	Drug: Placebo; Treatment group will receive prophylactic skin administration of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effect	Incidence of acute skin injury of Grade 2 or higher	from the start of radiotherapy to 3 months
≥ grade 2 acute skin injury	Incidence of acute skin injury of Grade 2 or higher	from the start of radiotherapy to 3 months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: radiation induced; radiationinduced
• Other Study ID Numbers: P-RIDermatitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No