KeraStat(R) Cream for Radiation Dermatitis

KeraNetics

Status: Completed

Conditions: Radiation Dermatitis

Treatments: Other: Standard of care; Device: KeraStat(R) Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03559218

KSCM-CRD-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Standard of care

Other group

Description:

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

Treatment:

Other: Standard of care

KeraStat Cream

Experimental group

Description:

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

Treatment:

Device: KeraStat(R) Cream