NCT02051907

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Kamedis Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
DEVICE	KAM1403 Gel
DEVICE	aloevera gel

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2014-01-31
• Last updated: 2014-01-31

Locations

1 site across 1 country: Israel