Radiation DermatitisNCT07086638
ROS-Scavenging Nanozyme Combined With Thermotherapy Alleviate Radiation Dermatitis in Patients With Head and Neck Cancer
A study testing Photo-responsive nanozyme in people with Radiation Dermatitis, run by West China Hospital at 1 site in China.
Trial summary
Severe radiation dermatitis remains a challenging complication in head and neck cancer with limited treatment options; this study aims to evaluate a novel Prussian blue-based nanozyme combined with near-infrared thermotherapy to promote effective healing of Grade III lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Photo-responsive nanozyme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2025to 25 Oct 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a pathological diagnosis of non-metastatic head and neck malignant tumors;
- Patients deemed suitable for high-dose radiotherapy, either as a primary treatment or as postoperative treatment following surgical resection.
Who cannot join
- Eastern Cooperative Oncology Group performance status of >2;
- Pre-existing skin rash, ulceration or open wound in the treatment area;
- Known allergy to trolamine or prussian blue;
- Inflammatory or connective tissue disorder of the skin;
- History of head and neck radiotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan University West China Hospital
Chengdu, Sichuan
Xingchen Peng, +86 18980606753, pxx2014@163.com
About this study
Official title: ROS-Scavenging Nanozyme Combined With Near-Infrared Thermotherapy for the Amelioration of Grade III Radiation Dermatitis in Patients With Head and Neck Cancer
Severe radiation dermatitis remains a challenging complication in head and neck cancer with limited treatment options; this study aims to evaluate a novel Prussian blue-based nanozyme combined with near-infrared thermotherapy to promote effective healing of Grade III lesions.
Read the detailed description
Radiation dermatitis is a common and challenging complication for patients undergoing radiotherapy, especially those with head and neck cancer. Currently, there are limited effective clinical treatments available for managing severe (Grade III) radiation-induced skin damage.
This study aims to explore a novel and safe treatment strategy for alleviating Grade III radiation dermatitis. The investigators use Prussian blue, an FDA-approved compound known for its reactive oxygen species (ROS) scavenging ability, formulated into a nanozyme that targets oxidative stress at the injury site. When combined with near-infrared (NIR) thermotherapy, this approach promotes faster skin repair and reduces inflammation.
This study's goal is to provide an effective and patient-friendly therapeutic option that accelerates healing and improves quality of life for individuals suffering from severe radiation dermatitis.
- Conditions
- Radiation Dermatitis
- Being tested
- Photo-responsive nanozyme
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo-responsive nanozymeDrug
The nanozyme scavenges ROS at the site of dermatitis and simultaneously responds to NIR light to generate mild heat, thereby promoting the healing of radiation-induced skin injury.
| Study group | Role | What they receive |
|---|---|---|
| Photo-responsive nanozyme | Experimental | The nanozyme scavenges ROS at the site of dermatitis and simultaneously responds to NIR light to generate mild heat, thereby promoting the healing of radiation-induced skin injury. Receives: Drug: Photo-responsive nanozyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade 3 radiation dermatitis
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.
Measured: From the onset of Grade III dermatitis to two weeks after the completion of radiotherapy
Secondary outcomes (1)
Bacterial load at the site of dermatitis
Experienced radiation oncology nurses took samples from the patients' radiation dermatitis areas, and professional medical laboratory nurses performed bacterial load analysis.
Measured: From the first administration of drug treatment through study completion, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start25 Jul 2025
- Primary completion30 May 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Principal investigator, Sichuan University West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086638
- Sponsor's protocol ID
- 2024-134-2
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 15 Apr 2026
- Results posted
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROS-Scavenging Nanozyme Combined With Near-Infrared Thermotherapy for the Amelioration of Grade III Radiation Dermatitis in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07086638
- Acronym / sponsor ID
- 2024-134-2
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 25 Jul 2025 (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.
Severe radiation dermatitis remains a challenging complication in head and neck cancer with limited treatment options; this study aims to evaluate a novel Prussian blue-based nanozyme combined with near-infrared thermotherapy to promote effective healing of Grade III lesions.
Detailed description
Radiation dermatitis is a common and challenging complication for patients undergoing radiotherapy, especially those with head and neck cancer. Currently, there are limited effective clinical treatments available for managing severe (Grade III) radiation-induced skin damage.
This study aims to explore a novel and safe treatment strategy for alleviating Grade III radiation dermatitis. The investigators use Prussian blue, an FDA-approved compound known for its reactive oxygen species (ROS) scavenging ability, formulated into a nanozyme that targets oxidative stress at the injury site. When combined with near-infrared (NIR) thermotherapy, this approach promotes faster skin repair and reduces inflammation.
This study's goal is to provide an effective and patient-friendly therapeutic option that accelerates healing and improves quality of life for individuals suffering from severe radiation dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photo-responsive nanozyme | Experimental | Drug: Photo-responsive nanozymeThe nanozyme scavenges ROS at the site of dermatitis and simultaneously responds to NIR light to generate mild heat, thereby promoting the healing of radiation-induced skin injury. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a pathological diagnosis of non-metastatic head and neck malignant tumors;
- Patients deemed suitable for high-dose radiotherapy, either as a primary treatment or as postoperative treatment following surgical resection.
Key exclusion criteria (5 listed)
- Eastern Cooperative Oncology Group performance status of >2;
- Pre-existing skin rash, ulceration or open wound in the treatment area;
- Known allergy to trolamine or prussian blue;
- Inflammatory or connective tissue disorder of the skin;
- History of head and neck radiotherapy.
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 |
|---|---|---|
| Photo-responsive nanozymeThe nanozyme scavenges ROS at the site of dermatitis and simultaneously responds to NIR light to generate mild heat, thereby promoting the healing of radiation-induced skin injury. | Drug | Photo-responsive nanozyme |
Primary outcome
The incidence of grade 3 radiation dermatitis
Time frame: From the onset of Grade III dermatitis to two weeks after the completion of radiotherapy
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.
1 secondary outcome
Bacterial load at the site of dermatitis
Time frame: From the first administration of drug treatment through study completion, an average of 1 month.
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 15 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Radiation Dermatitis
RecruitingPhase 2
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
Breast Cancer, Breast Cancer Female
RecruitingObservational study
Collecting Patient-Reported Experiences With Radiation Dermatitis in Breast Cancer Patients Undergoing Radiotherapy
Breast Carcinoma
RecruitingPhase 2
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
Radiation-induced Dermatitis
Not yet recruiting
Artificial Intelligence Powered Digital Education Based on the Neuman Systems Model for Breast Cancer Patients Receiving Radiotherap
Breast Cancer, Radiodermatitis
Not yet recruitingObservational study
Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
Head and Neck Neoplasms, Radiodermatitis
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.
Xingchen Peng principal investigator
Sichuan University West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photo-responsive nanozyme in people with Radiation Dermatitis, run by West China Hospital at 1 site 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 2 inclusion and 5 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 15 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 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Xingchen Peng (+86 18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade 3 radiation dermatitis (time frame: From the onset of Grade III dermatitis to two weeks after the completion of radiotherapy). 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 15 Apr 2026.