Radiation DermatitisNCT07399990
Efficacy of Superoxide Dismutase in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
A study testing Saline Spray and SOD spray in people with Radiation Dermatitis, run by West China Hospital.
Trial summary
Radiotherapy always results in many complications such as radiation dermatitis,dry mouth, cranial nerve damage, and swallowing function. Among them,radiation dermatitis is confirmed to occur in the majority of tumor patientsreceiving radiotherapy, which not only affects the appearance but also causesthe interruption… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Saline Spray and SOD spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; 2. Patients considered candidates for high-dose RT either as primary treatment or as postoperative treatment after surgical resection and patients planned to receive concomitant boost fractionation or concurrent systemic chemotherapy.
Who cannot join
- 1. Eastern Cooperative Oncology Group performance status of #2; 2. Pre-existing skin rash, ulceration or open wound in the treatment area; 3. Known allergy to trolamine or fullerene; 4. Inflammatory or connective tissue disorder of the skin; 5. History of head and neck radiotherapy.
About this study
Radiotherapy always results in many complications such as radiation dermatitis,dry mouth, cranial nerve damage, and swallowing function. Among them,radiation dermatitis is confirmed to occur in the majority of tumor patientsreceiving radiotherapy, which not only affects the appearance but also causesthe interruption of radiotherapy in severe cases.
At present, there is no standard treatment for radiation dermatitis. Superoxide dismutase (SOD) Spray is able to removefree radicals produced during radiotherapy, which may provide a new way andmethod for the prevention and treatment of radiation dermatitis. In addition,the product has obtained a safety assessment report from a third-party testingorganization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of superoxide dismutase (SOD) Spray in preventing radiationdermatitis in Head and Neck Cancer.
Read the detailed description
Radiotherapy is an essential modality in the curative and palliative management of head and neck malignancies, but it is frequently accompanied by a spectrum of acute and late toxicities, including radiation dermatitis, xerostomia, cranial nerve injury, and dysphagia. Radiation dermatitis, an inflammatory skin reaction to ionizing radiation, develops in the majority of patients undergoing external beam radiotherapy to the head and neck region and ranges from mild erythema and dry desquamation to moist desquamation and ulceration in severe cases. Clinically significant skin injury not only compromises patients' quality of life through pain, pruritus and cosmetic disfigurement, but may also necessitate treatment interruptions or dose reductions, which have been associated with inferior tumor control and survival outcomes in several studies.
The pathophysiology of radiation dermatitis is multifactorial and involves direct radiation-induced DNA damage, endothelial cell injury, cytokine-mediated inflammatory cascades, and generation of reactive oxygen species (ROS). ROS, particularly superoxide anions, play a central role in propagating oxidative stress, lipid peroxidation and subsequent tissue injury. Current management strategies for radiation dermatitis are largely supportive and empirical, including skin hygiene measures, topical corticosteroids, emollients, dressings for moist desquamation, and pain control; however, there is no universally accepted standard of care and robust high-quality evidence for many interventions remains limited.
Antioxidant-based topical and topical-delivery agents have been explored as prophylactic and therapeutic options to mitigate radiation-induced skin injury by neutralizing ROS and modulating inflammatory responses. Superoxide dismutase (SOD) is a key endogenous antioxidant enzyme that catalyzes the dismutation of superoxide radicals into oxygen and hydrogen peroxide, thereby reducing oxidative stress. Preclinical studies and early clinical reports suggest that SOD-containing formulations or SOD-mimetic compounds can decrease markers of oxidative damage, attenuate inflammatory signaling, and reduce histologic evidence of radiation-induced dermal injury.
The investigational SOD spray evaluated in this trial is formulated for topical aerosolized delivery to irradiated skin surfaces, which may offer advantages in ease of application, uniform coverage of complex anatomical regions in the head and neck, and patient compliance compared with creams. Early-phase studies of topical sprays delivering antioxidants or SOD-mimetic agents have demonstrated favorable tolerability and potential reductions in the severity of acute radiation dermatitis, though data remain limited and heterogeneous. The SOD spray in this study has undergone third-party safety assessment and meets human-use standards, supporting its tolerability for topical application.
Given the biological plausibility, encouraging preliminary data for antioxidant approaches, and the unmet clinical need for effective prophylaxis against radiation dermatitis, this randomized clinical trial aims to evaluate the efficacy and safety of SOD spray in preventing radiation dermatitis among patients with head and neck cancer undergoing definitive or adjuvant radiotherapy. Primary endpoints include incidence and maximal grade of acute radiation dermatitis based on standardized scoring systems, while secondary endpoints will assess time to onset, patient-reported skin symptoms and quality of life, treatment interruptions, and safety/tolerability metrics. The trial's findings may inform evidence-based recommendations for topical antioxidant prophylaxis in the radiotherapy setting and potentially improve treatment adherence and patient outcomes.
- Conditions
- Radiation Dermatitis
- Being tested
- Saline Spray, SOD spray
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline SprayOther
Patients are instructed to apply the saline spray to the treatment area twice daily, starting three days before radiotherapy (RT) and continuing until two weeks after treatment completion. The spray should be used to cover the entire treatment area. Patients are also advised not to use the spray within four hours before RT. They are required to keep the skin in the radiotherapy area dry and clean and to refrain from using other topical agents in the irradiated area. Use of the spray should be discontinued if dermatitis of grade 2 or higher occurs.
SOD sprayOther
Patients are instructed to apply a thin layer of SOD spray to the treatment area twice daily, beginning three days before radiotherapy (RT) and continuing until two weeks after treatment completion. The application should cover the entire treatment area. Patients are also advised not to use the spray within four hours before RT to avoid potential buildup effects. They are required to keep the skin in the radiotherapy area dry and clean and to refrain from using other topical agents in the irradiated area. Use of the spray should be discontinued if dermatitis of grade 2 or higher occurs.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Spray | Placebo comparator | Not described Receives: Other: Saline Spray |
| Superoxide dismutase (SOD) Spray | Experimental | Not described Receives: Other: SOD spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
he incidence of grade 2 or higher radiation dermatitis.
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 (7)
The time to onset of grade 2 or higher radiation dermatitis.
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
The duration of grade 2 or higher radiation dermatitis.
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.
The maximum skin toxicity.
The maximum grade of RTOG skin toxicity between 0 and 4.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The Skindex-16 instrument.
The Skindex-16 is a commonly used tool to measure the effect of skin diseases on the QoL of patients. Skindex-16 consists of domain scores that assess how symptoms, emotions, and functioning from the skin issue affect the QOL of patients with acne. The overall score averages the 3 domain scores, all of which are normalized to a 0 to 100 scale, where 0 indicates that their skin condition has no impact on QOL and 100 represents maximal impact on QOL for the worse.
Measured: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-C30.
The EORTC QLQ-C30 consists of five functional scales, nine symptom scales and one global quality of life (QoL) scale, and has been validated in an international setting.The questionnaire uses a four-point Likert scale to indicate the extent of problems experienced, ranging from 'not at all' to 'very much'. The answers for each domain are converted to a score ranging from 0 to 100#or functional scales, high scores represent a high level of QoL#and for symptom scales high scores indicate a poor QoL.
Measured: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-H&N35
The EORTC QLQ-H\&N35 covers issues specific to HNC patients and includes 18 symptom scales; it has been validated in an international setting and is used extensively in HRQoL research. The questionnaire uses a four-point Likert scale to indicate the extent of problems experienced, ranging from 'not at all' to 'very much'. The answers for each domain are converted to a score ranging from 0 to 100#or functional scales, high scores represent a high level of QoL#and for symptom scales high scores indicate a poor QoL.
Measured: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
Adverse events.
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version.
Measured: From 1 week before 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 posted10 Feb 2026
- Study start4 Feb 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Why it stopped: This study was withdrawn prior to enrollment due to administrative error in the registration process, specifically an incorrect ethics approval number was recorded. A corrected version of the study has been re-registered under a new record.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399990
- Sponsor's protocol ID
- HX2024-134-4
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 23 Jun 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Superoxide Dismutase in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
- ClinicalTrials.gov ID
- NCT07399990
- Acronym / sponsor ID
- HX2024-134-4
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn prior to enrollment due to administrative error in the registration process, specifically an incorrect ethics approval number was recorded. A corrected version of the study has been re-registered under a new record.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 4 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 10 Feb 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.
Radiotherapy always results in many complications such as radiation dermatitis,dry mouth, cranial nerve damage, and swallowing function. Among them,radiation dermatitis is confirmed to occur in the majority of tumor patientsreceiving radiotherapy, which not only affects the appearance but also causesthe interruption of radiotherapy in severe cases.
At present, there is no standard treatment for radiation dermatitis. Superoxide dismutase (SOD) Spray is able to removefree radicals produced during radiotherapy, which may provide a new way andmethod for the prevention and treatment of radiation dermatitis. In addition,the product has obtained a safety assessment report from a third-party testingorganization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of superoxide dismutase (SOD) Spray in preventing radiationdermatitis in Head and Neck Cancer.
Detailed description
Radiotherapy is an essential modality in the curative and palliative management of head and neck malignancies, but it is frequently accompanied by a spectrum of acute and late toxicities, including radiation dermatitis, xerostomia, cranial nerve injury, and dysphagia. Radiation dermatitis, an inflammatory skin reaction to ionizing radiation, develops in the majority of patients undergoing external beam radiotherapy to the head and neck region and ranges from mild erythema and dry desquamation to moist desquamation and ulceration in severe cases. Clinically significant skin injury not only compromises patients' quality of life through pain, pruritus and cosmetic disfigurement, but may also necessitate treatment interruptions or dose reductions, which have been associated with inferior tumor control and survival outcomes in several studies.
The pathophysiology of radiation dermatitis is multifactorial and involves direct radiation-induced DNA damage, endothelial cell injury, cytokine-mediated inflammatory cascades, and generation of reactive oxygen species (ROS). ROS, particularly superoxide anions, play a central role in propagating oxidative stress, lipid peroxidation and subsequent tissue injury. Current management strategies for radiation dermatitis are largely supportive and empirical, including skin hygiene measures, topical corticosteroids, emollients, dressings for moist desquamation, and pain control; however, there is no universally accepted standard of care and robust high-quality evidence for many interventions remains limited.
Antioxidant-based topical and topical-delivery agents have been explored as prophylactic and therapeutic options to mitigate radiation-induced skin injury by neutralizing ROS and modulating inflammatory responses. Superoxide dismutase (SOD) is a key endogenous antioxidant enzyme that catalyzes the dismutation of superoxide radicals into oxygen and hydrogen peroxide, thereby reducing oxidative stress. Preclinical studies and early clinical reports suggest that SOD-containing formulations or SOD-mimetic compounds can decrease markers of oxidative damage, attenuate inflammatory signaling, and reduce histologic evidence of radiation-induced dermal injury.
The investigational SOD spray evaluated in this trial is formulated for topical aerosolized delivery to irradiated skin surfaces, which may offer advantages in ease of application, uniform coverage of complex anatomical regions in the head and neck, and patient compliance compared with creams. Early-phase studies of topical sprays delivering antioxidants or SOD-mimetic agents have demonstrated favorable tolerability and potential reductions in the severity of acute radiation dermatitis, though data remain limited and heterogeneous. The SOD spray in this study has undergone third-party safety assessment and meets human-use standards, supporting its tolerability for topical application.
Given the biological plausibility, encouraging preliminary data for antioxidant approaches, and the unmet clinical need for effective prophylaxis against radiation dermatitis, this randomized clinical trial aims to evaluate the efficacy and safety of SOD spray in preventing radiation dermatitis among patients with head and neck cancer undergoing definitive or adjuvant radiotherapy. Primary endpoints include incidence and maximal grade of acute radiation dermatitis based on standardized scoring systems, while secondary endpoints will assess time to onset, patient-reported skin symptoms and quality of life, treatment interruptions, and safety/tolerability metrics. The trial's findings may inform evidence-based recommendations for topical antioxidant prophylaxis in the radiotherapy setting and potentially improve treatment adherence and patient outcomes.
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 |
|---|---|---|
| Normal Saline Spray | Placebo comparator | Other: Saline Spray |
| Superoxide dismutase (SOD) Spray | Experimental | Other: SOD spray |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; 2. Patients considered candidates for high-dose RT either as primary treatment or as postoperative treatment after surgical resection and patients planned to receive concomitant boost fractionation or concurrent systemic chemotherapy.
Key exclusion criteria (1 listed)
- 1. Eastern Cooperative Oncology Group performance status of #2; 2. Pre-existing skin rash, ulceration or open wound in the treatment area; 3. Known allergy to trolamine or fullerene; 4. Inflammatory or connective tissue disorder of the skin; 5. 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 |
|---|---|---|
| Saline SprayPatients are instructed to apply the saline spray to the treatment area twice daily, starting three days before radiotherapy (RT) and continuing until two weeks after treatment completion. The spray should be used to cover the entire treatment area. Patients are also advised not to use the spray within four hours before RT. They are required to keep the skin in the radiotherapy area dry and clean and to refrain from using other topical agents in the irradiated area. Use of the spray should be discontinued if dermatitis of grade 2 or higher occurs. | Other | Normal Saline Spray |
| SOD sprayPatients are instructed to apply a thin layer of SOD spray to the treatment area twice daily, beginning three days before radiotherapy (RT) and continuing until two weeks after treatment completion. The application should cover the entire treatment area. Patients are also advised not to use the spray within four hours before RT to avoid potential buildup effects. They are required to keep the skin in the radiotherapy area dry and clean and to refrain from using other topical agents in the irradiated area. Use of the spray should be discontinued if dermatitis of grade 2 or higher occurs. | Other | Superoxide dismutase (SOD) Spray |
Primary outcome
he incidence of grade 2 or higher radiation dermatitis.
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.
7 secondary outcomes
The time to onset of grade 2 or higher radiation dermatitis.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
The duration of grade 2 or higher radiation dermatitis.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The maximum skin toxicity.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The Skindex-16 instrument.
Time frame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-C30.
Time frame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-H&N35
Time frame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
Adverse events.
Time frame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Spray and SOD spray in people with Radiation Dermatitis, run by West China Hospital.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
he incidence of grade 2 or higher radiation dermatitis. (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 23 Jun 2026.