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NCT07704372
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
Conditions: Radiation-induced Dermatitis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 140
Sponsor: West China Hospital
Location: Sichuan University West China Hospital Chengdu Sichuan
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07704372). StuddyBuddy aggregates publicly available trial information.
