CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Spray skin protector +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04067310
NCT04067310N/ACompleted

Randomized, Open-label Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis in Patients With Anal and Rectal Canal Cancer.

Instituto Nacional de Cancer, Brazil·interventional·Posted Aug 26, 2019·Updated Dec 9, 2024

In Brief

A clinical study evaluating Spray skin protector and moisturizer Dnativ Revita derm for Radiodermatitis and Injury, Radiation. Completed, enrolled 72 participants across 1 site.

Detailed Summary

This is a randomized, open-label, single-institution trial designed to evaluate the effectiveness of a spray skin protector in preventing moist desquamation caused by radiotherapy treatment. This technology, spray skin protection, depending on the manufacturer, is primarily intended to prevent or reduce contact dermatitis. However, this study will be evaluated for use in preventing moist desquamation caused by ionizing radiation. The comparing agent will be a moisturizer, agreed upon at the local Institution of the study for use in the prevention of radiodermatitis. As secondary objectives: describe adverse events, diarrhea, pain and pruritus. The study will be conducted at the radiotherapy outpatient clinic of the Cancer Hospital I (HCI) of National Cancer Institute (INCA) in Brazil.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 26, 2019
Enrollment StartDec 16, 2020
Primary CompletionDec 30, 2022
Study CompletionJan 20, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.9 years ago

Interventions

Spray skin protectorother

Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.

moisturizer Dnativ Revita dermother

Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.