ConditionRadiation-induced Dermatitis
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 groupsSponsors and collaborators
Source ClinicalTrials.gov