Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Radiation-induced Dermatitis
• Intervention / Treatment: Other: Placebo Spray; Drug: A topical superoxide dismutase skin spray

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xingchen Peng; Phone Number: +86 18980606753; Email: pxx2014@163.com
• Study Contact Backup: Name: Yu Min; Phone Number: 13108175138

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan University West China Hospital
      • Contact: Xingchen Peng; Phone Number: +86 18980606753; Email: pxx2014@163.com
      • Contact: Yu Min; Phone Number: 13108175138

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically confirmed malignant tumors of the head and neck without distant metastasis.
2. Scheduled to undergo either postoperative adjuvant radiotherapy or definitive radiotherapy, with or without concurrent chemotherapy.
3. Age 18-80 years at the time of consent.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Signed informed consent form.
6. Adequate cognitive and reading abilities to complete the questionnaire.

Exclusion Criteria:

1. Pre-existing skin disease or open wounds in the irradiation field.
2. Have a history of head and neck radiotherapy.
3. Autoimmune or connective tissue disorders affecting skin.
4. Known allergy to any component of study formulations.
5. Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo excipient spray; A placebo spray consisting of the excipient formulation without superoxide dismutase, which is the same as the experimental group in appearance.	Other: Placebo Spray; 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.
Experimental: Superoxide dismutase containing skin spray; A topical skin spray containing superoxide dismutase	Drug: A topical superoxide dismutase skin spray; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the start of radiotherapy to 4 weeks after completion of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	From the start of radiotherapy to 4 weeks after completion of radiotherapy.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Health Status and Core Dimensions of Quality of Life	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) This instrument is a 30-item patient-reported outcome (PRO) measure designed to evaluate core aspects of health-related quality of life in cancer patients, including 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, pain, nausea and vomiting), one global health status/quality of life scale, and 6 single-item symptom measures. Scores are linearly transformed to a range of 0-100. For the functional scales and the global health status scale, higher scores indicate better functional levels or quality of life; for the symptom scales/items, higher scores indicate greater symptom burden.	The total evaluation period is approximately 14 to 14.5 weeks.
Head and Neck Cancer-Specific Symptoms	The EORTC QLQ-H&N35 is a patient-reported outcome (PRO) instrument specifically designed to assess disease-related symptoms and treatment-related side effects in patients with head and neck cancer. It comprises 35 items, organized into seven multi-item subscales (pain, swallowing, senses, speech, social eating, social contact, and sexuality) and eleven single-item measures (such as dental problems, problems opening mouth, sticky saliva, coughing, etc.). All subscale and single-item scores are linearly transformed to a 0-100 scale using a standardized scoring algorithm. Interpretation of Scores: For all subscales and single items, higher scores represent more severe symptoms or greater symptom burden.	The total evaluation period is approximately 14 to 14.5 weeks.
Radiotherapy interruption rate	Radiotherapy interruption is defined as an unplanned prolongation of the radiotherapy schedule resulting in a delay of ≥5 days compared with the planned treatment schedule, excluding scheduled breaks.	Up to 8 weeks (from initiation to completion of radiotherapy)
Patient-reported skin symptoms from the Skindex-16	The Skindex-16 is a commonly used tool to measure the effect of skin diseases on the skin-related 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.	From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
Skin microbiome composition and diversity	Skin microbiome composition and diversity will be assessed as an exploratory endpoint using 16S rRNA gene sequencing. Skin swab samples will be collected from the irradiated skin area at baseline (before radiotherapy initiation) and at completion of radiotherapy.	Baseline and end of radiotherapy (approximately 8 weeks after radiotherapy initiation)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version.	From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Xingchen Peng, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: superoxide dismutase; Head & neck cancer; Radiation-induced Dermatitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms by Site; Neoplasms; Skin Diseases; Radiation Injuries; Dermatitis; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Radiodermatitis
• Other Study ID Numbers: 2026(819)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No