KeraStat(R) Cream for Radiation Dermatitis

NCT ID: NCT03559218

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2018-11-06

Brief Summary

The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.

Detailed Description

The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.

The secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin.

Conditions

Radiation Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care

Group Type: OTHER

Standard of care

Intervention Type: OTHER

Patients will be instructed to follow institutional standard of care for radiation dermatitis

KeraStat Cream

Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.

Group Type: EXPERIMENTAL

KeraStat(R) Cream

Intervention Type: DEVICE

KeraStat Cream is a cream wound dressing that contains 5% keratin.

Interventions

KeraStat(R) Cream

KeraStat Cream is a cream wound dressing that contains 5% keratin.

Intervention Type: DEVICE

Standard of care

Patients will be instructed to follow institutional standard of care for radiation dermatitis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 70

2. Female

3. Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)

4. Able and willing to sign protocol consent form

5. Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes

6. Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria

1. Women who are pregnant, lactating/nursing or plan to become pregnant

2. Previous radiation therapy to the area to be treated with radiation therapy

3. Receiving palliative radiation therapy

4. Unhealed or infected surgical sites in the irradiation area

5. Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)

6. Use of oral corticosteroids or topical corticosteroids in the irradiation area

7. Autoimmune disease

8. Skin disease in target irradiation area

9. Known allergy to the standard of care or ingredients in KeraStat Cream

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KeraNetics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Winfield, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

KSCM-CRD-001

Identifier Type: -

Identifier Source: org_study_id