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

Phase 2

• Conditions: Radiation Dermatitis
• Interventions: Device: KAM1403 Gel; Device: aloevera gel

• Registration Number: NCT02051907
• Lead Sponsor: Kamedis Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Last Update Submitted: 2014-01-30
• Study First Posted: 2014-01-31
• Last Update Posted: 2014-01-31
• Study Start: 2014-03
• Primary Completion: 2015-03
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KAM1403 Gel	KAM1403 Gel	A group treated with KAM1403 for the study period.
Aloevera Gel	aloevera gel	A group treated with Aloevera Gel for the study period

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Adverse Events	Day 0, weeks 2, 4, 6.5, 8.5
Subjects' self evaluation	Day 0, weeks 2, 4, 6.5, 8.5

Trial Locations

Locations (1)

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel