Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

This study is currently recruiting participants.
Verified September 2013 by Sir Mortimer B. Davis - Jewish General Hospital
Sponsor:
Collaborator:
Avario Healthcare Inc.
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01701466
First received: October 3, 2012
Last updated: September 26, 2013
Last verified: September 2013

October 3, 2012
September 26, 2013
December 2011
December 2014   (final data collection date for primary outcome measure)
Maximum skin toxicity [ Time Frame: 7 weeks post beginning of radiation treatments ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01701466 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Head and Neck Cancer
  • Breast Cancer
  • Other: Aveeno cream
    Twice a day
  • Other: Flamazine cream
    Twice a day, when there is dry desquamation
  • Other: NeoVIDERM cream
    Three times a day
  • 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.
    Interventions:
    • Other: Aveeno cream
    • Other: Flamazine cream
    • Other: NeoVIDERM cream
  • 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.
    Interventions:
    • Other: Aveeno cream
    • Other: Flamazine cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Chantal Cadieux, PhD 1-514-340-8222 ext 6199 ccadieux@jgh.mcgillca
Canada
 
NCT01701466
11-053
No
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
Sir Mortimer B. Davis - Jewish General Hospital
Avario Healthcare Inc.
Principal Investigator: Te Vuong, MD Jewish General Hospital
Sir Mortimer B. Davis - Jewish General Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP