An observational study in Radiation Dermatitis, sponsored by Stratpharma AG. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by Stratpharma AG · Observational
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.
127 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.
This study's enrollment of 344 is above the median of 40 across 14 observational studies indexed under Radiodermatitis.
Browse Radiodermatitis studies →Stratpharma AG is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Head and neck cancer patients treated with radiation therapy at UCLA from 2010 to 2022
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: StrataXRT
Drug: Calendula · Drug: Aquaphor
StrataXRT® is a TGA-approved silicone-based topical preparation. StrataXRT is a self-drying, non-sticky, transparent, silicone gel formulation and when used as directed, dries to form an inert, thin, flexible wound dressing with a protective layer that is gas permeable and waterproof. It is the only self-drying topical silicone gel indicated for the use on radiation dermatitis, which hydrates and protects compromised skin areas and open wounds from chemical and microbial invasion. StrataXRT helps create an optimal wound healing environment which leads to faster re-epithelialization and a reduced inflammatory response. The product can be applied to fresh incisions and excisions, open wounds and compromised skin surfaces.
Calendula creams are over-the-counter (OTC) skin care ointments that are non-greasy, non-sticky, and quickly absorbed by the skin. Calendula is a topical agent derived from a plant of the marigold family Calendula Officinalis and is used in cuts, scrapes, chafing and minor burns. Containing numerous polyphenolic antioxidants, calendula has been studied in both the laboratory and clinical setting for the use in treating and preventing radiation induced skin toxicity.
Aquaphor, containing 41 percent petrolatum (or petroleum jelly), temporarily protects minor cuts, scrapes, and burns; Aquaphor protects and helps relieve chapped or cracked skin and lips, as well as helps protecting from the drying effects of wind and cold weather.
CTCAE for Radiation Dermatitis
Acute radiation dermatitis measured weekly during radiotherapy treatment, using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score (grade 0 - 5). A higher grade is considered a worse outcome.
Time frame: 5 weeks
CTCAE for Hyperpigmentation
Acute hyperpigmentation measured weekly during radiotherapy treatment, using the Common Terminology Criteria for Adverse Events (CTCAE) score (grade 0 - 2). A higher grade is considered a worse outcome.
Time frame: 5 weeks
Number of patients requiring burn cream application
Total number of patients that required burn cream application during radiotherapy
Time frame: 5 weeks
Interval between radiotherapy start and burn cream application
Number of days between initiation of radiation therapy and first application of burn cream during radiotherapy
Time frame: 5 weeks
Number of patients requiring Mepilex application
Total number of patients that required Mepilex application during radiotherapy
Time frame: 5 weeks
Interval between radiotherapy start and Mepilex application
Number of days between initiation of radiation therapy and first application of Mepilex during radiotherapy
Time frame: 5 weeks
Ran from May 2023 to primary completion in Sep 2023, 4 months.
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Stratpharma AG