Clinical trial · Interventional
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
NCT07704372CI-TRIAL-00118114not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation-induced Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A topical superoxide dismutase skin spray | Drug | — | UNRESOLVED |
| Placebo Spray | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo excipient spray
- description
- A placebo spray consisting of the excipient formulation without superoxide dismutase, which is the same as the experimental group in appearance.
- interventionNames
- Other: Placebo Spray
- type
- EXPERIMENTAL
- label
- Superoxide dismutase containing skin spray
- description
- A topical skin spray containing superoxide dismutase
- interventionNames
- Drug: A topical superoxide dismutase skin spray
Primary outcomes (1)
- measure
- Incidence of grade ≥ 2 ARD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.