- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01701466
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria: For patients receiving radiation to the breast
- Patients receiving a dose of at least 50 Gy in 25 fractions with concomitant chemotherapy or treated with the McGill technique.
- Patients able to understand and sign an informed consent form.
- Patients that do not have active connective tissue disorders.
- Patients 18 years or older.
- Patients that did not receive any previous radiation.
- Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
- 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
- Patients receiving radiotherapy on fields that include both sides of the neck
- Patients able to understand and sign an informed consent form.
- Patients that do not have active connective tissue disorders.
- Patients 18 years or older.
- Patients that did not receive any previous radiation.
- Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
- 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
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
- Allergic to any ingredient in Neoviderm cream
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Twice a day
Twice a day, when there is dry desquamation
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.
|
Twice a day
Twice a day, when there is dry desquamation
|
What is the study measuring?
Primary Outcome Measures
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
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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