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Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis.

NCT04067310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-12-09

Study results available
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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.

Conditions

  • Radiodermatitis
  • Injury, Radiation

Interventions

OTHER

Spray skin protector

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

OTHER

moisturizer Dnativ Revita derm

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

Sponsors & Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    collaborator OTHER_GOV

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Principal Investigators

  • Fabiana V Simões · Universidade Federal do Rio de Janeiro (UFRJ)

  • Rafael C Silva · Universidade Federal do Rio de Janeiro (UFRJ)

  • Beatriz G R B Oliveira · Universidade Federal Fluminense (UFF)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2022-12-30
Completion
2023-01-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04067310 on ClinicalTrials.gov