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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Sourasky Medical Center
Tel Aviv, Israel
Changes in Radiation dermatitis symptoms
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
Time frame: Day 0, weeks 2, 4, 6.5, 8.5
Subjects' self evaluation
Time frame: Day 0, weeks 2, 4, 6.5, 8.5
Number of Adverse Events
Time frame: Day 0, weeks 2, 4, 6.5, 8.5
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