[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647110":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo excipient spray","PLACEBO_COMPARATOR","A placebo spray consisting of the excipient formulation without superoxide dismutase, which is the same as the experimental group in appearance.",[13],"Other: Placebo Spray",{"label":15,"type":16,"description":17,"interventionNames":18},"Superoxide dismutase containing skin spray","EXPERIMENTAL","A topical skin spray containing superoxide dismutase",[19],"Drug: A topical superoxide dismutase skin spray",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[9],[32],{"name":33,"affiliation":34,"role":35},"Xingchen Peng","Study Principal Investigator","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+86 18980606753","pxx2014@163.com",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":26},"Yu Min","13108175138",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Sichuan University West China Hospital","Chengdu","Sichuan","610041","China","CN",{"type":53,"coordinates":54},"Point",[55,56],104.06667,30.66667,{"lat":56,"lon":55},[59,60],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":42,"role":38,"phone":43,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":33,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PhD, Professor","100647110","phase-2-superoxide-dismutase-skin-spray-for-the-prevention-of-acute-radiation-dermatitis-in-head-and-neck-cancer-100647110",false,"NCT07704372","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","Inclusion Criteria:\n\n1. Histologically confirmed malignant tumors of the head and neck without distant metastasis.\n2. Scheduled to undergo either postoperative adjuvant radiotherapy or definitive radiotherapy, with or without concurrent chemotherapy.\n3. Age 18-80 years at the time of consent.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Signed informed consent form.\n6. Adequate cognitive and reading abilities to complete the questionnaire.\n\nExclusion Criteria:\n\n1. Pre-existing skin disease or open wounds in the irradiation field.\n2. Have a history of head and neck radiotherapy.\n3. Autoimmune or connective tissue disorders affecting skin.\n4. Known allergy to any component of study formulations.\n5. Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.","ALL","18 Years","80 Years",{"count":74,"type":75},140,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","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.",[81],"Radiation-induced Dermatitis",[83,81,84],"Head & neck cancer","superoxide dismutase","NOT_YET_RECRUITING","2026-07-09",{"date":88,"type":89},"2026-07-15","ACTUAL",{"date":88,"type":75},{"date":92,"type":75},"2027-04-30",{"name":5,"class":6},1]