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Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01701466
Recruitment Status : Terminated
First Posted : October 5, 2012
Last Update Posted : May 25, 2015
Sponsor:
Collaborator:
Avario Healthcare Inc.
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital

Tracking Information
First Submitted Date  ICMJE October 3, 2012
First Posted Date  ICMJE October 5, 2012
Last Update Posted Date May 25, 2015
Study Start Date  ICMJE December 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Head and Neck Cancer
  • Breast Cancer
Intervention  ICMJE
  • Other: Aveeno cream
    Twice a day
  • Other: Flamazine cream
    Twice a day, when there is dry desquamation
  • Other: NeoVIDERM cream
    Three times a day
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 3, 2014)
14
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2012)
60
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01701466
Other Study ID Numbers  ICMJE 11-053
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
Study Sponsor  ICMJE Sir Mortimer B. Davis - Jewish General Hospital
Collaborators  ICMJE Avario Healthcare Inc.
Investigators  ICMJE
Principal Investigator: Te Vuong, MD Jewish General Hospital
PRS Account Sir Mortimer B. Davis - Jewish General Hospital
Verification Date May 2015

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