Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

May 22, 2015 updated by: Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital

A Phase II Study Designed to Evaluate the Value of Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria: For patients receiving radiation to the breast

  1. Patients receiving a dose of at least 50 Gy in 25 fractions with concomitant chemotherapy or treated with the McGill technique.
  2. Patients able to understand and sign an informed consent form.
  3. Patients that do not have active connective tissue disorders.
  4. Patients 18 years or older.
  5. Patients that did not receive any previous radiation.
  6. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
  7. Patients need to be able to apply the creams themselves or have help with applying the creams.

Inclusion criteria: For patients receiving radiation to the head and neck

  1. Patients receiving radiotherapy on fields that include both sides of the neck
  2. Patients able to understand and sign an informed consent form.
  3. Patients that do not have active connective tissue disorders.
  4. Patients 18 years or older.
  5. Patients that did not receive any previous radiation.
  6. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
  7. Patients need to be able to apply the creams themselves or have help with applying the creams.

Exclusion criteria: For patients receiving radiation to the breast or the head and neck

  1. Patients that have a type V or type VI skin type according to the Fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it).

    The Fitzpatrick Scale:

    • Type I (scores 0-7) White; very fair; freckles. Always burns, never tans
    • Type II (scores 8-16) White; fair. Usually burns, tans with difficulty
    • Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans
    • Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin.

    Rarely burns, tans with ease

    • Type V (scores over 30) Dark brown. Very rarely burns, tans very easily
    • Type VI Black. Never burns, tans very easily
  2. Allergic to any ingredient in Neoviderm cream

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Arm B: standard of care plus 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.
Other: Aveeno cream
Twice a day
Other: Flamazine cream
Twice a day, when there is dry desquamation
Other: NeoVIDERM cream
Three times a day
ACTIVE_COMPARATOR: Arm A: standard skin care
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.
Other: Aveeno cream
Twice a day
Other: Flamazine cream
Twice a day, when there is dry desquamation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum skin toxicity
Time Frame: 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.
7 weeks post beginning of radiation treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sir Mortimer B. Davis - Jewish General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avario Healthcare Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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