Trial Outcomes & Findings for KeraStat(R) Cream for Radiation Dermatitis (NCT NCT03559218)
NCT ID: NCT03559218
Last Updated: 2021-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
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.
Results posted on
2021-09-09
Participant Flow
Participant milestones
| Measure |
Standard of Care
Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
Standard of care: 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.
KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Standard of Care
Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
Standard of care: 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.
KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
One subject withdrew at baseline prior to treatment and was not included.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=11 Participants
Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis
|
KeraStat Cream
n=13 Participants
Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • One subject withdrew at baseline prior to treatment and was not included.
|
0 Participants
n=7 Participants • One subject withdrew at baseline prior to treatment and was not included.
|
0 Participants
n=5 Participants • One subject withdrew at baseline prior to treatment and was not included.
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants • One subject withdrew at baseline prior to treatment and was not included.
|
7 Participants
n=7 Participants • One subject withdrew at baseline prior to treatment and was not included.
|
12 Participants
n=5 Participants • One subject withdrew at baseline prior to treatment and was not included.
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants • One subject withdrew at baseline prior to treatment and was not included.
|
6 Participants
n=7 Participants • One subject withdrew at baseline prior to treatment and was not included.
|
12 Participants
n=5 Participants • One subject withdrew at baseline prior to treatment and was not included.
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Radiation Therapy Oncology Group Skin Toxicity Grade (RTOG)
|
0 units on a scale (RTOG)
STANDARD_DEVIATION 0 • n=5 Participants
|
0 units on a scale (RTOG)
STANDARD_DEVIATION 0 • n=7 Participants
|
0 units on a scale (RTOG)
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Dermatology Life Quality Index
|
2.73 units on a scale
STANDARD_DEVIATION 5.12 • n=5 Participants
|
0.31 units on a scale
STANDARD_DEVIATION 0.85 • n=7 Participants
|
1.42 units on a scale
STANDARD_DEVIATION 3.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: One subject missed visit 5. One subject missed visit 6. Subject #18 missed visit 7.
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.
Outcome measures
| Measure |
Standard of Care
n=11 Participants
Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis
|
KeraStat Cream
n=13 Participants
Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.
|
|---|---|---|
|
Radiation Therapy Oncology Group Skin Toxicity Scoring
Visit 1
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 0.0
|
|
Radiation Therapy Oncology Group Skin Toxicity Scoring
Visit 2
|
0.09 score on a scale
Interval 0.0 to 1.0
|
0.15 score on a scale
Interval 0.0 to 1.0
|
|
Radiation Therapy Oncology Group Skin Toxicity Scoring
Visit 3
|
0.55 score on a scale
Interval 0.0 to 1.0
|
0.62 score on a scale
Interval 0.0 to 1.0
|
|
Radiation Therapy Oncology Group Skin Toxicity Scoring
Visit 4
|
0.82 score on a scale
Interval 0.0 to 1.0
|
1.00 score on a scale
Interval 0.0 to 2.0
|
|
Radiation Therapy Oncology Group Skin Toxicity Scoring
Visit 5
|
1.00 score on a scale
Interval 0.0 to 2.0
|
1.17 score on a scale
Interval 0.0 to 2.0
|
|
Radiation Therapy Oncology Group Skin Toxicity Scoring
Visit 6
|
1.36 score on a scale
Interval 0.0 to 2.0
|
1.00 score on a scale
Interval 0.0 to 1.0
|
|
Radiation Therapy Oncology Group Skin Toxicity Scoring
Visit 7
|
0.30 score on a scale
Interval 0.0 to 1.0
|
0.23 score on a scale
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: 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.Population: One subject missed visit 5. One subject missed visit 6. Subject #18 missed visit 7.
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.
Outcome measures
| Measure |
Standard of Care
n=11 Participants
Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis
|
KeraStat Cream
n=13 Participants
Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.
|
|---|---|---|
|
Dermatology Life Quality Index
Visit 1
|
2.73 units on a scale (DQLI score)
Interval 0.0 to 18.0
|
0.31 units on a scale (DQLI score)
Interval 0.0 to 3.0
|
|
Dermatology Life Quality Index
Visit 2
|
1.64 units on a scale (DQLI score)
Interval 0.0 to 6.0
|
0.77 units on a scale (DQLI score)
Interval 0.0 to 5.0
|
|
Dermatology Life Quality Index
Visit 3
|
1.91 units on a scale (DQLI score)
Interval 0.0 to 7.0
|
2.23 units on a scale (DQLI score)
Interval 0.0 to 15.0
|
|
Dermatology Life Quality Index
Visit 4
|
2.36 units on a scale (DQLI score)
Interval 0.0 to 7.0
|
2.85 units on a scale (DQLI score)
Interval 0.0 to 11.0
|
|
Dermatology Life Quality Index
Visit 5
|
5.27 units on a scale (DQLI score)
Interval 0.0 to 15.0
|
4.75 units on a scale (DQLI score)
Interval 0.0 to 26.0
|
|
Dermatology Life Quality Index
Visit 6
|
6.18 units on a scale (DQLI score)
Interval 0.0 to 17.0
|
4.25 units on a scale (DQLI score)
Interval 0.0 to 14.0
|
|
Dermatology Life Quality Index
Visit 7
|
1.00 units on a scale (DQLI score)
Interval 0.0 to 6.0
|
0.85 units on a scale (DQLI score)
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 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.Evaluate safety and tolerability of application of KeraStat Cream through comparison of adverse events reported in KeraStat Cream group versus standard of care.
Outcome measures
| Measure |
Standard of Care
n=12 Participants
Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
Standard of care: Patients will be instructed to follow institutional standard of care for radiation dermatitis
|
KeraStat Cream
n=13 Participants
Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
KeraStat(R) Cream: KeraStat Cream is a cream wound dressing that contains 5% keratin.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
KeraStat Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place