Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

Phase 2

Terminated

• Conditions: Head and Neck Cancer; Breast Cancer
• Interventions: Other: Aveeno cream; Other: Flamazine cream; Other: NeoVIDERM cream

• Registration Number: NCT01701466
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Brief Summary

The purpose of this study is to determine whether NeoVIDERM is effective at preventing radiation dermatitis in patients receiving external beam radiation therapy to the head and neck or breast areas.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-05
• Primary Completion: 2014-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: standard of care plus NeoVIDERM cream	Aveeno cream	Patients will apply NeoVIDERM cream to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. Patients will also perform standard of care skin treatment.
Arm A: standard skin care	Aveeno cream	Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatments. If they develop dry desquamation, they will be asked to apply Flamazine twice a day until dermatitis resolves.
Arm B: standard of care plus NeoVIDERM cream	Flamazine cream	Patients will apply NeoVIDERM cream to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. Patients will also perform standard of care skin treatment.
Arm A: standard skin care	Flamazine cream	Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatments. If they develop dry desquamation, they will be asked to apply Flamazine twice a day until dermatitis resolves.
Arm B: standard of care plus NeoVIDERM cream	NeoVIDERM cream	Patients will apply NeoVIDERM cream to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. Patients will also perform standard of care skin treatment.

Primary Outcome Measures

Name	Time	Method
Maximum skin toxicity	7 weeks post beginning of radiation treatments	The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of neoVIDERM compared to patients treated with institutional standard skin care.

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada