Trial Outcomes & Findings for Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy (NCT NCT04173247)
NCT ID: NCT04173247
Last Updated: 2025-03-17
Results Overview
Feasibility of use of KeraStat Cream is measured by participant compliance with an average of 10 or more applications per week being classified as complaint. In each arm, a 95% confidence interval will be calculated around the estimate of compliance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Up to 1 month post treatment with radiation therapy (6-7 weeks)
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
KeraStat Skin Cream Arm
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
KeraStat Skin Cream Arm
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy
Baseline characteristics by cohort
| Measure |
KeraStat Skin Cream Arm
n=12 Participants
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
n=12 Participants
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
n=99 Participants
|
64.5 years
n=107 Participants
|
64 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 1 month post treatment with radiation therapy (6-7 weeks)Feasibility of use of KeraStat Cream is measured by participant compliance with an average of 10 or more applications per week being classified as complaint. In each arm, a 95% confidence interval will be calculated around the estimate of compliance.
Outcome measures
| Measure |
KeraStat Skin Cream Arm
n=12 Participants
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
n=12 Participants
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Completion Rate of Use of KeraStat Cream
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 1 month post treatment with radiation therapy (6-7 weeks)Tolerability is measured by the number of patients who discontinue skin care regimen due to intolerance for any reason. In each arm, a 95% confidence interval will be calculated around the estimate of tolerability.
Outcome measures
| Measure |
KeraStat Skin Cream Arm
n=12 Participants
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
n=12 Participants
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Number of Participants Discontinuing Skin Care Regimen
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 month post treatment with radiation therapy (6-7 weeks)Objective assessment of early adverse skin reaction defined as Grade 2+ using the CTCAE version 5.0 scale of radiation dermatitis will be compared between the KeraStat group and the RSC group at the end of treatment, using a Fisher's exact test.
Outcome measures
| Measure |
KeraStat Skin Cream Arm
n=12 Participants
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
n=12 Participants
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Number of Participants With Grade 2+ Radiation Dermatitis
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 1 month post treatment with radiation therapyPatient-reported assessment of skin toxicity using the PRO-CTCAE version 1.0 scale of radiation skin symptoms (skin dryness, itching, radiation skin reaction and skin darkening). Score scale is none to very severe and Yes or No for skin darkening.
Outcome measures
| Measure |
KeraStat Skin Cream Arm
n=12 Participants
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
n=12 Participants
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Number of Participants Reporting Radiation Skin Reaction
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At weeks 1-6 and up to 1 month post treatment with radiation therapyPopulation: Dlqi scores below are averaged over weeks 1-6
A 10-item questionnaire to measure how skin problems have affected participants' lives. Scoring for each question ranges from 0-3 with very much scored as 3 and not at all or not relevant score as 0. The DLQI is calculated by summing the score of each questions resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. The mean of the highest DLQI score across all time points will be compared between the KeraStat and RSC groups using a t-test.
Outcome measures
| Measure |
KeraStat Skin Cream Arm
n=12 Participants
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
n=12 Participants
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Dermatology Life Quality Index Questionnaire
|
1.5 units on a scale
Standard Deviation 2.5
|
1.9 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Up to 1 month post treatment with radiation therapy (7 weeks)Population: Number of tubes over 7 weeks, in KeraStat arm only
Skin coverage is defined as the total number of tubes of KeraStat Cream used over 7 weeks OVER ALL participants in the KeraStat arm only.
Outcome measures
| Measure |
KeraStat Skin Cream Arm
n=12 Participants
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage
|
49 total number of tubes of KeraStat used
|
—
|
Adverse Events
KeraStat Skin Cream Arm
Serious events: 3 serious events
Other events: 2 other events
Deaths: 1 deaths
Routine Skin Care Arm (RSC Arm)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KeraStat Skin Cream Arm
n=12 participants at risk
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
n=12 participants at risk
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Gastrointestinal disorders
Small intestinal perforation
|
8.3%
1/12 • Number of events 1 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
0.00%
0/12 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 1 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
0.00%
0/12 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.3%
1/12 • Number of events 1 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
0.00%
0/12 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
Other adverse events
| Measure |
KeraStat Skin Cream Arm
n=12 participants at risk
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
KeraStat Cream: KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
|
Routine Skin Care Arm (RSC Arm)
n=12 participants at risk
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Routine Skin Care - Commercially Available Agents: Commercially available skin moisturizers from an approved list that do not interfere with radiation.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
8.3%
1/12 • Number of events 1 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/12 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
8.3%
1/12 • Number of events 1 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
8.3%
1/12 • Number of events 1 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Number of events 1 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
0.00%
0/12 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
|
Investigations
Weight loss
|
8.3%
1/12 • Number of events 1 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
0.00%
0/12 • Up to 1 month post treatment with radiation therapy (6-7 weeks)
|
Additional Information
Study Coordinator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-4760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place