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Feasibility in the Prophylaxis of Radiation Dermatitis Severity

Terminated
Conditions
Radiation Dermatitis
Interventions
Drug: StrataXRT
Registration Number
NCT04715386
Lead Sponsor
Mayo Clinic
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
14
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
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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)
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Group 1- StrataXRTStrataXRT-
Primary Outcome Measures
NameTimeMethod
To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs.First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days
Secondary Outcome Measures
NameTimeMethod
Patient reported outcomesUpon study completion, on average 6 weeks, but will vary per patient

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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

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