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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWest China Hospital

About this trial

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

Qualifiers

Histologically confirmed malignant tumors of the head and neck without distant metastasis.

Scheduled to undergo either postoperative adjuvant radiotherapy or definitive radiotherapy, with or without concurrent chemotherapy.

Age 18-80 years at the time of consent.

Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Disqualifiers

Pre-existing skin disease or open wounds in the irradiation field.

Have a history of head and neck radiotherapy.

Autoimmune or connective tissue disorders affecting skin.

Known allergy to any component of study formulations.

Trial design

Treatments tested in this trial

  • A topical superoxide dismutase skin spray
  • Placebo Spray

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators