Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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A BLIND, CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KAM1403 GEL TREATMENT IN PATIENTS WITH RADIATION DERMATITIS

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Device: KAM1403 Gel
* Device: aloevera gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KAM1403 Gel<br>A group treated with KAM1403 for the study period. | Device: KAM1403 Gel<br> <br> |
| Sham Comparator: Aloevera Gel<br>A group treated with Aloevera Gel for the study period | Device: aloevera gel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |