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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KAM1403 Gel | Experimental | A group treated with KAM1403 for the study period. |
|
| Aloevera Gel | Sham Comparator | A group treated with Aloevera Gel for the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAM1403 Gel | Device |
| ||
| aloevera gel |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0, weeks 2, 4, 6.5, 8.5 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helena Gryner, M.Sc. | Contact | +972 73 7969040 | Helena@Kamedis.com |
| Name | Affiliation | Role |
|---|---|---|
| Diana Matchiavsky, MD | Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sourasky Medical Center | Tel Aviv | Israel |
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| Label | URL |
|---|---|
| Sponsor's site | View source |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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|
| D014947 |
| Wounds and Injuries |