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

NCT07704372 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026(819)
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation-induced Dermatitis

Keywords

Head & neck cancer; Radiation-induced Dermatitis; superoxide dismutase

Outcome Measures

Primary Outcomes (1)

• Incidence of grade ≥ 2 ARD

  Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

Secondary Outcomes (4)

• Time to onset of grade ≥ 2 ARD between the two arms.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

• Duration of grade ≥ 2 ARD between the two arms.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

• Maximum dermatitis grade

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

• Grade ≥3 radiation dermatitis incidence

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

Other Outcomes (6)

• Radiotherapy interruption rate

  Up to 8 weeks (from initiation to completion of radiotherapy)

• Patient-reported skin symptoms from the Skindex-16

  From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.

• Overall Health Status and Core Dimensions of Quality of Life

  The total evaluation period is approximately 14 to 14.5 weeks.

Study Arms (2)

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.

Other: Placebo Spray

Superoxide dismutase containing skin spray

EXPERIMENTAL

A topical skin spray containing superoxide dismutase

Drug: A topical superoxide dismutase skin spray

Interventions

A topical superoxide dismutase skin spray DRUG

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.

Superoxide dismutase containing skin spray

Placebo Spray OTHER

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.

Placebo excipient spray

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Signed informed consent form.
• Adequate cognitive and reading abilities to complete the questionnaire.

You may not qualify if:

• 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.
• Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Sichuan University West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Radiodermatitis; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms

Study Officials

• Xingchen Peng

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng

CONTACT

+86 18980606753; pxx2014@163.com

Yu Min

CONTACT

13108175138

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 15, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)