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

Primary Purpose

Radiation Dermatitis

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
KAM1403 Gel
aloevera gel
Sponsored by
Kamedis Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

KAM1403 Gel

Aloevera Gel

Arm Description

A group treated with KAM1403 for the study period.

A group treated with Aloevera Gel for the study period

Outcomes

Primary Outcome Measures

Changes in Radiation dermatitis symptoms
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

Subjects' self evaluation
Number of Adverse Events

Full Information

First Posted
January 30, 2014
Last Updated
January 30, 2014
Sponsor
Kamedis Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02051907
Brief Title
Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis
Acronym
kam1403
Official Title
A BLIND, CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KAM1403 GEL TREATMENT IN PATIENTS WITH RADIATION DERMATITIS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kamedis Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KAM1403 Gel
Arm Type
Experimental
Arm Description
A group treated with KAM1403 for the study period.
Arm Title
Aloevera Gel
Arm Type
Sham Comparator
Arm Description
A group treated with Aloevera Gel for the study period
Intervention Type
Device
Intervention Name(s)
KAM1403 Gel
Intervention Type
Device
Intervention Name(s)
aloevera gel
Primary Outcome Measure Information:
Title
Changes in Radiation dermatitis symptoms
Description
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
Time Frame
Day 0, weeks 2, 4, 6.5, 8.5
Secondary Outcome Measure Information:
Title
Subjects' self evaluation
Time Frame
Day 0, weeks 2, 4, 6.5, 8.5
Title
Number of Adverse Events
Time Frame
Day 0, weeks 2, 4, 6.5, 8.5

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Gryner, M.Sc.
Phone
+972 73 7969040
Email
Helena@Kamedis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Matchiavsky, MD
Organizational Affiliation
Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Matchiavsky, MD
Phone
972 3 697 4815
Email
dianam@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Diana Matchiavsky, MD

12. IPD Sharing Statement

Links:
URL
http://www.kamedis.com
Description
Sponsor's site

Learn more about this trial

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

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