Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

• ClinicalTrials.gov Identifier: NCT01701466
• Recruitment Status: Terminated
• First Posted: October 5, 2012
• Last Update Posted: May 25, 2015
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborator: Avario Healthcare Inc.
• Information provided by (Responsible Party): Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital

Tracking Information

• First Submitted Date: October 3, 2012
• First Posted Date: October 5, 2012
• Last Update Posted Date: May 25, 2015
• Study Start Date: December 2011
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Head and Neck Cancer
• Breast Cancer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 3, 2014): 14
• Original Estimated Enrollment (submitted: October 4, 2012): 60
• Study Completion Date: Not Provided
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01701466
• Other Study ID Numbers: 11-053
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
• Study Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborators: Avario Healthcare Inc.

Investigators

• Principal Investigator: Te Vuong, MD; Jewish General Hospital

• PRS Account: Sir Mortimer B. Davis - Jewish General Hospital
• Verification Date: May 2015