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NCT05810194 · ClinicalTrials.gov registry record
Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis
A clinical trial, sponsored by Stratpharma.
- Completed
- Registry status
- 344
- Enrollment target
NCT05810194: Completed study, sponsored by Stratpharma.
NCT05810194 is a clinical trial that has completed, run by Stratpharma. The registered enrollment target is 344 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05810194 has completed, sponsored by Stratpharma.
- COMPLETED
- Registry status
- 344 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Aquaphor
- DEVICE StrataXRT
- DRUG Calendula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2023-12-31 |
What the finished NCT05810194 record still lists
NCT05810194 is an observational study that tracks outcomes without assigning an intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Aquaphor is the first listed.
NCT05810194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05810194 about?
NCT05810194 is a clinical study titled "Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis". 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 ...
What is the current status of trial NCT05810194?
This trial is currently completed. The enrollment target is 344 participants. The study started on 2023-05-01. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT05810194?
The interventions under investigation include: Aquaphor (DRUG), StrataXRT (DEVICE), Calendula (DRUG).
Who is sponsoring clinical trial NCT05810194?
This trial is sponsored by Stratpharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
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