Clinical trial · Observational
Feasibility in the Prophylaxis of Radiation Dermatitis Severity
Evaluation of Feasibility in the Prophylaxis of Radiation Dermatitis Severity in Cancer Patients
NCT04715386CI-TRIAL-00073881terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual; investigator retired
Summary
Brief summary (as posted)
To compare radiation dermatitis severity in irradiated skin protected by an agent verses uncovered skin based on photographs and track patient reported outcomes with use of the agent.
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 Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| StrataXRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1- StrataXRT
- interventionNames
- Drug: StrataXRT
Primary outcomes (1)
- measure
- To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs.
- timeFrame
- First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days
Secondary outcomes (1)
- measure
- Patient reported outcomes
- timeFrame
- Upon study completion, on average 6 weeks, but will vary per patient
- description
- Patients will be asked to complete a survey at the end of study that will ask them to provide feedback on the agent used during their treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18years * Undergoing external beam radiotherapy for head/neck cancer at Mayo Clinic Rochester campus. Note: patients undergoing concurrent chemotherapy are eligible. * Able to provide informed written consent * Willing to consent for photography of radiation field * Receiving a dose ≥ 45 Gy and 20 fractions to both the area being treated and the area being used for comparison Exclusion Criteria: * Patients with active rash, pre-existing dermatitis, lupus, tattoos, scleroderma or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion. * Patients with known allergic and other systemic skin diseases even if not directly affecting irradiated fields. * Any medical condition that in the opinion of the investigator should exclude him/her from participating in the study. * Enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit * The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)
References
Publications (0)
Data not yet available
No reference posted for this study.