Radiation-induced DermatitisPhase 2NCT07704372
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
A Phase 2 study testing A topical superoxide dismutase skin spray in people with Radiation-induced Dermatitis, run by West China Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of superoxide dismutase skin spray for the reducing the acute radiation dermatitis in patients with head and neck malignancies undergoing radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation-induced Dermatitis
- What is being tested?
- A topical superoxide dismutase skin spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2026to 28 Feb 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed malignant tumors of the head and neck without distant metastasis.
- Scheduled to undergo either postoperative adjuvant radiotherapy or definitive radiotherapy, with or without concurrent chemotherapy.
- Age 18-80 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Signed informed consent form.
- Adequate cognitive and reading abilities to complete the questionnaire.
Who cannot join
- Pre-existing skin disease or open wounds in the irradiation field.
- Have a history of head and neck radiotherapy.
- Autoimmune or connective tissue disorders affecting skin.
- Known allergy to any component of study formulations.
- Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yu Min contact
China1 site, 1 recruiting
- Recruiting
Sichuan University West China Hospital
Chengdu, Sichuan, 610041
Xingchen Peng, Ph.D., +86 18980606753, pxx2014@163.com
Yu Min, 13108175138
About this study
Official title: Superoxide Dismutase Skin Spray for Reducing Acute Radiation Dermatitis in Patients With Head and Neck Cancer Undergoing Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
To evaluate the efficacy and safety of superoxide dismutase skin spray for the reducing the acute radiation dermatitis in patients with head and neck malignancies undergoing radiotherapy.
Read the detailed description
Radiotherapy (RT) is a cornerstone treatment for patients with head and neck cancer and may be administered as definitive, adjuvant, or concurrent therapy with chemotherapy depending on disease stage and clinical indication. Despite its therapeutic benefits, RT is frequently associated with a range of acute toxicities, among which radiation dermatitis is one of the most common and clinically relevant adverse effects. Radiation-induced skin injury may present during or shortly after the course of radiotherapy and can significantly impact patient comfort, treatment adherence, and overall quality of life. Severe cases may lead to treatment interruption or dose modification, potentially compromising oncologic outcomes. The incidence of acute radiation dermatitis in patients with head and neck cancer has been reported to be high, with a substantial proportion of patients developing at least moderate-grade skin reactions during the course of radiotherapy. However, current preventive and therapeutic strategies remain limited, and no universally accepted standard of care has been established. Existing supportive measures are primarily empirical and have shown variable efficacy in reducing the severity or progression of skin toxicity. Superoxide dismutase (SOD) is an endogenous antioxidant enzyme with the ability to catalyze the dismutation of superoxide radicals into oxygen and hydrogen peroxide, thereby reducing oxidative stress-induced cellular damage. Given that oxidative stress is a key mechanism underlying radiation-induced skin injury, topical application of SOD-based formulations may provide a biologically plausible approach for mitigating radiation dermatitis. Based on this rationale, the present clinical trial is designed to investigate the efficacy and safety of a topical SOD skin spray in preventing and reducing acute radiation dermatitis in patients with head and neck cancer undergoing radiotherapy.
- Conditions
- Radiation-induced Dermatitis
- Being tested
- A topical superoxide dismutase skin spray, Placebo Spray
- Keywords
- Head & neck cancer, Radiation-induced Dermatitis, superoxide dismutase
- Medical subject headings
- Radiodermatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A topical superoxide dismutase skin sprayDrug
Patients are instructed to apply a topical superoxide dismutase-containing spray evenly to the entire radiotherapy-treated skin area, approximately 3 sprays per application, five times daily. Treatment is initiated at the start of radiotherapy and continued until the occurrence of grade ≥2 radiation dermatitis or up to one week after completion of radiotherapy, whichever occurs first. Patients are instructed to keep the irradiated skin clean and dry and to avoid the use of other topical agents in the treatment area.
Placebo SprayOther
Patients are instructed to apply a placebo excipient spray without superoxide dismutase evenly to the entire radiotherapy-treated skin area, approximately 3 sprays per application, five times daily, following the same schedule as the experimental group. Treatment is initiated at the start of radiotherapy and continued until the occurrence of grade ≥2 radiation dermatitis or up to one week after completion of radiotherapy, whichever occurs first. Patients are instructed to keep the irradiated skin clean and dry and to avoid the use of other topical agents in the treatment area.
| Study group | Role | What they receive |
|---|---|---|
| Placebo excipient spray | Placebo comparator | A placebo spray consisting of the excipient formulation without superoxide dismutase, which is the same as the experimental group in appearance. Receives: Other: Placebo Spray |
| Superoxide dismutase containing skin spray | Experimental | A topical skin spray containing superoxide dismutase Receives: Drug: A topical superoxide dismutase skin spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥ 2 ARD
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Secondary outcomes (4)
Time to onset of grade ≥ 2 ARD between the two arms.
Time from the first day of radiotherapy to the first determination of grade 2 or higher radiation dermatitis.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Duration of grade ≥ 2 ARD between the two arms.
The first determination of grade 2 or higher radiation dermatitis to the first instance of grade 1 or 0 radiation dermatitis, without a subsequent instance of grade 2 or higher radiation dermatitis. Patients without observed grade 2 or higher radiation dermatitis were assigned a duration of 0 days.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Maximum dermatitis grade
The maximum grade of RTOG skin toxicity between 0 and 4.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Grade ≥3 radiation dermatitis incidence
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start28 Sep 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 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, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704372
- Sponsor's protocol ID
- 2026(819)
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2026
- Last updated
- 29 Oct 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superoxide Dismutase Skin Spray for Reducing Acute Radiation Dermatitis in Patients With Head and Neck Cancer Undergoing Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07704372
- Acronym / sponsor ID
- 2026(819)
- Conditions
- Radiation-induced Dermatitis
- Keywords
- Head & neck cancer, Radiation-induced Dermatitis, superoxide dismutase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 15 Jul 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.
To evaluate the efficacy and safety of superoxide dismutase skin spray for the reducing the acute radiation dermatitis in patients with head and neck malignancies undergoing radiotherapy.
Detailed description
Radiotherapy (RT) is a cornerstone treatment for patients with head and neck cancer and may be administered as definitive, adjuvant, or concurrent therapy with chemotherapy depending on disease stage and clinical indication. Despite its therapeutic benefits, RT is frequently associated with a range of acute toxicities, among which radiation dermatitis is one of the most common and clinically relevant adverse effects. Radiation-induced skin injury may present during or shortly after the course of radiotherapy and can significantly impact patient comfort, treatment adherence, and overall quality of life. Severe cases may lead to treatment interruption or dose modification, potentially compromising oncologic outcomes. The incidence of acute radiation dermatitis in patients with head and neck cancer has been reported to be high, with a substantial proportion of patients developing at least moderate-grade skin reactions during the course of radiotherapy. However, current preventive and therapeutic strategies remain limited, and no universally accepted standard of care has been established. Existing supportive measures are primarily empirical and have shown variable efficacy in reducing the severity or progression of skin toxicity. Superoxide dismutase (SOD) is an endogenous antioxidant enzyme with the ability to catalyze the dismutation of superoxide radicals into oxygen and hydrogen peroxide, thereby reducing oxidative stress-induced cellular damage. Given that oxidative stress is a key mechanism underlying radiation-induced skin injury, topical application of SOD-based formulations may provide a biologically plausible approach for mitigating radiation dermatitis. Based on this rationale, the present clinical trial is designed to investigate the efficacy and safety of a topical SOD skin spray in preventing and reducing acute radiation dermatitis in patients with head and neck cancer undergoing radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo excipient spray | Placebo comparator | Other: Placebo SprayA placebo spray consisting of the excipient formulation without superoxide dismutase, which is the same as the experimental group in appearance. |
| Superoxide dismutase containing skin spray | Experimental | Drug: A topical superoxide dismutase skin sprayA topical skin spray containing superoxide dismutase |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed malignant tumors of the head and neck without distant metastasis.
- Scheduled to undergo either postoperative adjuvant radiotherapy or definitive radiotherapy, with or without concurrent chemotherapy.
- Age 18-80 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Signed informed consent form.
Key exclusion criteria (5 listed)
- Pre-existing skin disease or open wounds in the irradiation field.
- Have a history of head and neck radiotherapy.
- Autoimmune or connective tissue disorders affecting skin.
- Known allergy to any component of study formulations.
- Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.
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 |
|---|---|---|
| A topical superoxide dismutase skin sprayPatients are instructed to apply a topical superoxide dismutase-containing spray evenly to the entire radiotherapy-treated skin area, approximately 3 sprays per application, five times daily. Treatment is initiated at the start of radiotherapy and continued until the occurrence of grade ≥2 radiation dermatitis or up to one week after completion of radiotherapy, whichever occurs first. Patients are instructed to keep the irradiated skin clean and dry and to avoid the use of other topical agents in the treatment area. | Drug | Superoxide dismutase containing skin spray |
| Placebo SprayPatients are instructed to apply a placebo excipient spray without superoxide dismutase evenly to the entire radiotherapy-treated skin area, approximately 3 sprays per application, five times daily, following the same schedule as the experimental group. Treatment is initiated at the start of radiotherapy and continued until the occurrence of grade ≥2 radiation dermatitis or up to one week after completion of radiotherapy, whichever occurs first. Patients are instructed to keep the irradiated skin clean and dry and to avoid the use of other topical agents in the treatment area. | Other | Placebo excipient spray |
Primary outcome
Incidence of grade ≥ 2 ARD
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.
4 secondary outcomes
Time to onset of grade ≥ 2 ARD between the two arms.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Duration of grade ≥ 2 ARD between the two arms.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Maximum dermatitis grade
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Grade ≥3 radiation dermatitis incidence
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Yu Min contact
Xingchen Peng principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A topical superoxide dismutase skin spray in people with Radiation-induced 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 6 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 29 Oct 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. 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 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?
Incidence of grade ≥ 2 ARD (time frame: From the start of radiotherapy to 4 weeks after 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 29 Oct 2026.