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

NCT04067310 | Completed Results

• 1 other identifier: PROT
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

barrier film; spray skin protection; liquid-film; barrier product

Outcome Measures

Primary Outcomes (1)

• Number of Participants Categorized by RTOG Grading Scale

  RTOG ACUTE Radiation Morbidity - Tissue: Skin * Grade 1: Follicular, faint or dull erythema / epilation / dry desquamation / decreased sweating; * Grade 2: Tender or bright erythema, patchy moist desquamation / moderate edema; * Grade 3: Confluent, moist desquamation other than skin folds, pitting edema; * Grade 4: Ulceration, hemorrhage, necrosis.

  From the first day of radiotherapy up to eight weeks

Secondary Outcomes (1)

• Adverse Events

  From the first day of radiotherapy up to eight weeks

Study Arms (2)

Group Experimental

EXPERIMENTAL

Participants who will use the spray skin protector

Other: Spray skin protector

Group control

ACTIVE COMPARATOR

Participants who will use moisturizer Dnativ Revita Derm.

Other: moisturizer Dnativ Revita derm

Interventions

Spray skin protector OTHER

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

Also known as: barrier film to prevent radiodermatitis

Group Experimental

moisturizer Dnativ Revita derm OTHER

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

Also known as: conventional treatment to prevent radiodermatitis

Group control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

INCA Research Center

Rio de Janeiro, Rio de Janeiro, 20231092, Brazil

Location

MeSH Terms

Conditions

Radiodermatitis; Radiation Injuries

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Limitations and Caveats

The small sample size was a methodological limitation. When the COVID-19 pandemic emerged, the institution reduced the number of vacancies in the regulation system for the radiotherapy outpatient clinic of the HCI-INCA. Other factor that hindered attracting participants was the opening of new vacancies for radiotherapy in other institutions that had been closed until then.

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Instituto Nacional do Câncer

cecilia.silva@inca.gov.br

+552132076549

Study Officials

• Fabiana V Simões

  Universidade Federal do Rio de Janeiro (UFRJ)

  PRINCIPAL INVESTIGATOR

• Rafael C Silva

  Universidade Federal do Rio de Janeiro (UFRJ)

  PRINCIPAL INVESTIGATOR

• Beatriz G R B Oliveira

  Universidade Federal Fluminense (UFF)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will be in skin evaluation and statistical analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Nurse

Model Details: After signing the Informed Consent Form, randomization will be carried out in two groups: Experimental, which will use the skin protector in spray and control, which will use the moisturizer Dnativ Revita Derm.

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 26, 2019
• Study Start: December 16, 2020
• Primary Completion: December 30, 2022
• Study Completion: January 20, 2023
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Locations

BR (1)