Pinoxin for the Prevention of Radiation-Induced Skin Injury

NCT07545720 | Recruiting Phase 2

• 1 other identifier: P-RIDermatitis
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer Patients Undergoning Radiotherapy

Keywords

radiation induced; radiationinduced

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

treatment

EXPERIMENTAL

Receiving prophylactic skin administration of Pinoxin.

Drug: pinoxin

control

PLACEBO COMPARATOR

Receiving prophylactic skin administration of placebo.

Drug: Placebo

Interventions

pinoxin DRUG

Treatment group will receive prophylactic skin administration of Pinoxin，which is kind of Skin Protective Agent.

treatment

Placebo DRUG

Treatment group will receive prophylactic skin administration of placebo

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Central Study Contacts

Zhen Zhang, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: September 5, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)