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

January 30, 2014 updated by: Kamedis Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Diana Matchiavsky, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: KAM1403 Gel
A group treated with KAM1403 for the study period.
Device: KAM1403 Gel
SHAM_COMPARATOR: Aloevera Gel
A group treated with Aloevera Gel for the study period
Device: aloevera gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0, weeks 2, 4, 6.5, 8.5

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjects' self evaluation
Time Frame: Day 0, weeks 2, 4, 6.5, 8.5
Day 0, weeks 2, 4, 6.5, 8.5
Number of Adverse Events
Time Frame: Day 0, weeks 2, 4, 6.5, 8.5
Day 0, weeks 2, 4, 6.5, 8.5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kamedis Ltd.

Investigators

  • Principal Investigator: Diana Matchiavsky, MD, Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

March 1, 2015

Study Completion (ANTICIPATED)

April 1, 2015

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (ESTIMATE)

January 31, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAM-RAD-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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