Back to resultsKeraStat(R) Cream for Radiation Dermatitis
Primary Purpose
Radiation Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KeraStat(R) Cream
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 70
- Female
- Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
- Able and willing to sign protocol consent form
- Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
- Able and willing to have photographs of the affected area taken regularly
Exclusion Criteria:
- Women who are pregnant, lactating/nursing or plan to become pregnant
- Previous radiation therapy to the area to be treated with radiation therapy
- Receiving palliative radiation therapy
- Unhealed or infected surgical sites in the irradiation area
- Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
- Use of oral corticosteroids or topical corticosteroids in the irradiation area
- Autoimmune disease
- Skin disease in target irradiation area
- Known allergy to the standard of care or ingredients in KeraStat Cream
Sites / Locations
- Wake Forest School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard of care
KeraStat Cream
Arm Description
Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03559218
Brief Title
KeraStat(R) Cream for Radiation Dermatitis
Official Title
Pilot Study: KeraStat(R) Cream for Radiation Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KeraNetics, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Other
Arm Description
Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
Arm Title
KeraStat Cream
Arm Type
Experimental
Arm Description
Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
Intervention Type
Device
Intervention Name(s)
KeraStat(R) Cream
Intervention Description
KeraStat Cream is a cream wound dressing that contains 5% keratin.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Patients will be instructed to follow institutional standard of care for radiation dermatitis
Primary Outcome Measure Information:
Title
Radiation Therapy Oncology Group Skin Toxicity Scoring
Description
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.
Title
Dermatology Life Quality Index
Description
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 Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 70
Female
Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
Able and willing to sign protocol consent form
Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
Able and willing to have photographs of the affected area taken regularly
Exclusion Criteria:
Women who are pregnant, lactating/nursing or plan to become pregnant
Previous radiation therapy to the area to be treated with radiation therapy
Receiving palliative radiation therapy
Unhealed or infected surgical sites in the irradiation area
Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
Use of oral corticosteroids or topical corticosteroids in the irradiation area
Autoimmune disease
Skin disease in target irradiation area
Known allergy to the standard of care or ingredients in KeraStat Cream
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Winfield, MD PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
KeraStat(R) Cream for Radiation Dermatitis
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