Radiation Dermatitis
Conditions
Brief summary
The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema, moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of subjects treated with the Aloe vera Gel (the control group). In addition, a comparison will be made between subjects' self evaluation in the treatment group versus the control group. Safety will be determined by the number and severity of Adverse Events Device-Related.
Interventions
DEVICEKAM1403 Gel
DEVICEaloevera gel
Sponsors
Kamedis Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female above 18 years of age * 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
* Tumor involvement of the skin * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Radiation dermatitis symptoms | Day 0, weeks 2, 4, 6.5, 8.5 | Changes in Radiation dermatitis symptoms assessment during and post radiotherapy (erythema, desquamation, edema, moist desquamation and ulceration) using the Radiation Therapy Oncology Group toxicity scoring system in the treatment group versus the control group |
Secondary
| Measure | Time frame |
|---|---|
| Subjects' self evaluation | Day 0, weeks 2, 4, 6.5, 8.5 |
| Number of Adverse Events | Day 0, weeks 2, 4, 6.5, 8.5 |
Countries
Israel
Contacts
Primary ContactHelena Gryner, M.Sc.
Outcome results
None listed