Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis (kam1403)

Kamedis

Status and phase: Unknown; Phase 2

Conditions: Radiation Dermatitis

Treatments: Device: aloevera gel; Device: KAM1403 Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02051907

KAM-RAD-01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

KAM1403 Gel

Experimental group

Description:

A group treated with KAM1403 for the study period.

Treatment:

Device: KAM1403 Gel

Aloevera Gel

Sham Comparator group

Description:

A group treated with Aloevera Gel for the study period

Treatment:

Device: aloevera gel