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NOT YET RECRUITING
NCT07704372
PHASE2

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-07-15

Completion Date

2027-04-30

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

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.

OTHER

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.

Locations (1)

Sichuan University West China Hospital

Chengdu, Sichuan, China