Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis
NCT ID: NCT02051907
Last Updated: 2014-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2014-03-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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KAM1403 Gel
A group treated with KAM1403 for the study period.
KAM1403 Gel
Aloevera Gel
A group treated with Aloevera Gel for the study period
aloevera gel
Interventions
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KAM1403 Gel
aloevera gel
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with breast cancer and scheduled to receive postoperative radiotherapy
* Treatment of regional lymph nodes (i.e. axillary, supraclavicular, or internal mammary) is allowed.
* Schedule for breast radiotherapy (RT) to a dose of 50 Gy in 2 Gy/fx, for 5 weeks and then a boost to the lumpectomy cavity.
* Minimum of 3 weeks from chemotherapy to start of radiation therapy.
* Patient agrees to use only the test products during the study period
Exclusion Criteria
* Patient has another dermatological disease/condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
* Patient has a previous history of allergy to the ingredients of the tested formulations
* Paget's disease of the nipple.
* Pregnant or lactating females
18 Years
FEMALE
No
Sponsors
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Kamedis Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Diana Matchiavsky, MD
Role: PRINCIPAL_INVESTIGATOR
Sourasky Medical Center
Locations
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Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Diana Matchiavsky, MD
Role: primary
Related Links
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Sponsor's site
Other Identifiers
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KAM-RAD-01
Identifier Type: -
Identifier Source: org_study_id