Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients Undergoning Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pinoxin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- treatment
- description
- Receiving prophylactic skin administration of Pinoxin.
- interventionNames
- Drug: pinoxin
- type
- PLACEBO_COMPARATOR
- label
- control
- description
- Receiving prophylactic skin administration of placebo.
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- adverse effect
- timeFrame
- from the start of radiotherapy to 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available