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

NCT02051907 | Unknown Phase 2

• 1 other identifier: KAM-RAD-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Subjects' self evaluation

  Day 0, weeks 2, 4, 6.5, 8.5

• Number of Adverse Events

  Day 0, weeks 2, 4, 6.5, 8.5

Study Arms (2)

KAM1403 Gel

EXPERIMENTAL

A group treated with KAM1403 for the study period.

Device: KAM1403 Gel

Aloevera Gel

SHAM COMPARATOR

A group treated with Aloevera Gel for the study period

Device: aloevera gel

Interventions

KAM1403 Gel DEVICE

KAM1403 Gel

aloevera gel DEVICE

Aloevera Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kamedis Ltd.: lead

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

Related Links

• Sponsor's site

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Diana Matchiavsky, MD

  Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Gryner, M.Sc.

CONTACT

+972 73 7969040; Helena@Kamedis.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: January 31, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

IL (1)