KeraStat(R) Cream for Radiation Dermatitis

KeraNetics, LLC25 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Radiation Dermatitis

Interventions

KeraStat(R) CreamDEVICE

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

Standard of careOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Radiation Therapy Oncology Group Skin Toxicity Scoring

The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point.

Time frame: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.

Dermatology Life Quality Index

The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups.

Time frame: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.

Secondary Outcomes

Number of Participants With Adverse Events

Evaluate safety and tolerability of application of KeraStat Cream through comparison of adverse events reported in KeraStat Cream group versus standard of care.

Time frame: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.

Data from ClinicalTrials.gov

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