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

Radiation Dermatitis Clinical Trial

— kam1403  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02051907
• Other study ID #: KAM-RAD-01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 30, 2014
• Last updated: January 30, 2014
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2014
• Source: Kamedis Ltd.
• Contact: Helena Gryner, M.Sc.
• Phone: +972 73 7969040
• Email: Helena[@]Kamedis.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Radiation Dermatitis
• Radiodermatitis

Intervention

Device:
• KAM1403 Gel

• aloevera gel

Locations

Country	Name	City	State
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Kamedis Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0, weeks 2, 4, 6.5, 8.5	No
Secondary	Subjects' self evaluation		Day 0, weeks 2, 4, 6.5, 8.5	No
Secondary	Number of Adverse Events		Day 0, weeks 2, 4, 6.5, 8.5	Yes

External Links

•   Sponsor's site