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

Sichuan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Radiation-induced Dermatitis

Treatments: Other: Placebo Spray; Drug: A topical superoxide dismutase skin spray

Study type: Interventional

Funder types: Other

Identifiers

NCT07704372

2026(819)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Placebo excipient spray

Placebo Comparator group

Description:

A placebo spray consisting of the excipient formulation without superoxide dismutase, which is the same as the experimental group in appearance.

Treatment:

Other: Placebo Spray

Superoxide dismutase containing skin spray

Experimental group

Description:

A topical skin spray containing superoxide dismutase

Treatment:

Drug: A topical superoxide dismutase skin spray