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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: Kamedis Ltd.

Current Primary Outcome: Changes in Radiation dermatitis symptoms [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subjects' self evaluation [ Time Frame: Day 0, weeks 2, 4, 6.5, 8.5 ]
  • Number of Adverse Events [ Time Frame: Day 0, weeks 2, 4, 6.5, 8.5 ]


Original Secondary Outcome: Same as current

Information By: Kamedis Ltd.

Dates:
Date Received: January 30, 2014
Date Started: March 2014
Date Completion: April 2015
Last Updated: January 30, 2014
Last Verified: January 2014