Cancer Patients Undergoning RadiotherapyPhase 2NCT07545720
Pinoxin for the Prevention of Radiation-Induced Skin Injury
A Phase 2 study testing pinoxin in people with Cancer Patients Undergoning Radiotherapy, run by Fudan University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients Undergoning Radiotherapy
- What is being tested?
- pinoxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 2 sitesChina
- Study dates
- 5 Sep 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhen Zhang, +86-021-64175590, zhen_zhang@fudan.edu.cn
Zhen Zhang, MD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Zhen Zhang, MD, +86-021-64175590, zhen_zhang@fudan.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer Patients Undergoning Radiotherapy
- Being tested
- pinoxin, Placebo
- Keywords
- radiation induced, radiationinduced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pinoxinDrug
Treatment group will receive prophylactic skin administration of Pinoxin，which is kind of Skin Protective Agent.
PlaceboDrug
Treatment group will receive prophylactic skin administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Receiving prophylactic skin administration of Pinoxin. Receives: Drug: pinoxin |
| control | Placebo comparator | Receiving prophylactic skin administration of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse effect
Incidence of acute skin injury of Grade 2 or higher
Measured: from the start of radiotherapy to 3 months
≥ grade 2 acute skin injury
Incidence of acute skin injury of Grade 2 or higher
Measured: from the start of radiotherapy to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start5 Sep 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients Undergoning RadiotherapyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545720
- Sponsor's protocol ID
- P-RIDermatitis
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Double-Blind Clinical Study of Hydrogen-Donor Modified SOD (Pinoxin) for the Prevention of Radiation-Induced Skin Injury
- ClinicalTrials.gov ID
- NCT07545720
- Acronym / sponsor ID
- P-RIDermatitis
- Conditions
- Cancer Patients Undergoning Radiotherapy
- Keywords
- radiation induced, radiationinduced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: pinoxinReceiving prophylactic skin administration of Pinoxin. |
| control | Placebo comparator | Drug: PlaceboReceiving prophylactic skin administration of placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pinoxinTreatment group will receive prophylactic skin administration of Pinoxin，which is kind of Skin Protective Agent. | Drug | treatment |
| PlaceboTreatment group will receive prophylactic skin administration of placebo | Drug | control |
Primary outcome
adverse effect
Time frame: from the start of radiotherapy to 3 months
Incidence of acute skin injury of Grade 2 or higher
≥ grade 2 acute skin injury
Time frame: from the start of radiotherapy to 3 months
Incidence of acute skin injury of Grade 2 or higher
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pinoxin in people with Cancer Patients Undergoning Radiotherapy, run by Fudan University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Zhang, MD (+86-021-64175590, zhen_zhang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse effect (time frame: from the start of radiotherapy to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.