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

Radiotherapy (RT) is a cornerstone treatment for patients with head and neck cancer andmay be administered as definitive, adjuvant, or concurrent therapy with chemotherapydepending on disease stage and clinical indication. Despite its therapeutic benefits, RTis frequently associated with a range of acute toxicities, among which radiationdermatitis is one of the most common and clinically relevant adverse effects.Radiation‐induced skin injury may present during or shortly after the course ofradiotherapy and can significantly impact patient comfort, treatment adherence, andoverall quality of life. Severe cases may lead to treatment interruption or dosemodification, potentially compromising oncologic outcomes. The incidence of acuteradiation 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 skinreactions during the course of radiotherapy. However, current preventive and therapeuticstrategies remain limited, and no universally accepted standard of care has beenestablished. Existing supportive measures are primarily empirical and have shown variableefficacy in reducing the severity or progression of skin toxicity. Superoxide dismutase(SOD) is an endogenous antioxidant enzyme with the ability to catalyze the dismutation ofsuperoxide radicals into oxygen and hydrogen peroxide, thereby reducing oxidativestress‐induced cellular damage. Given that oxidative stress is a key mechanism underlyingradiation‐induced skin injury, topical application of SOD‐based formulations may providea biologically plausible approach for mitigating radiation dermatitis. Based on thisrationale, the present clinical trial is designed to investigate the efficacy and safetyof a topical SOD skin spray in preventing and reducing acute radiation dermatitis inpatients with head and neck cancer undergoing radiotherapy.