Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis

Completed

Conditions studied: Radiation Dermatitis

In brief

Routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. Data will be split into two cohorts: patients that received 1) StrataXRT and 2) standard of care. The incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.

Key facts

Study ID

NCT05810194

Run by

Stratpharma AG

People needed

344

Starts

2023-05-01

Expected to finish

2023-12-31

Last updated by the study team

2024-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with Head and Neck cancer treated with radiation therapy with or without chemotherapy
• Fractionated courses including at least 30 fractions (treatments)
• Minimum of 18 completed radiation treatments
• Radiation dose: > 50 Gy
• Radiation technique: IMRT
• Radiation equipment: TrueBeam or Tomotherapy

You may not qualify if…

• Prior radiation to the treatment area
• Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
• Patients undergoing SBRT
• Patients with existing rashes or wounds in the target region or radiation therapy at RT start
• Patients receiving hypofractionation
• Patient receiving bolus

Where it is running

• University of California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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