Head and Neck CancerNCT04173247
Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy
A study testing KeraStat Cream and Routine Skin Care - Commercially Available Agents in people with Head and Neck Cancer and Radiation Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Radiation Dermatitis
- What is being tested?
- KeraStat Cream and Routine Skin Care - Commercially Available Agents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 7 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of head and neck cancer planned to receive conventionally-fractionated definitive radiotherapy to the head and neck to a total prescribed dose of at least 60 Gy
- Able and willing to sign protocol consent form
- Able and willing to complete tolerability and quality of life assessments
- Able and willing to have photographs of the affected area taken regularly
Who cannot join
- Women who are pregnant, lactating/nursing or plan to become pregnant
- Previous radiation therapy to the area to be treated with radiation therapy
- Active, medically necessary use of topical corticosteroids in the irradiation area
- Active scleroderma or lupus requiring systemic medication
- Treatment with anti-EGFR antibodies for head and neck cancer (previously or planned)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Pilot Study of KeraStat® Cream for Radiation Dermatitis During Head and Neck Radiotherapy
This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck.
Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.
Read the detailed description
Primary Objective(s)
- To determine the feasibility of the use of KeraStat Cream in patients receiving radiotherapy for head and neck cancer.
Secondary Objective(s)
- To determine the tolerability of KeraStat Cream in patients receiving radiotherapy for head and neck cancer compared to routine skin care.
- To assess the effectiveness of KeraStat Cream in reducing the severity of EASR in patients receiving radiotherapy for head and neck cancer, compared to routine skin care. This will be performed by evaluating:
- Objective evaluation of EASR using the CTCAE Version 5.0 scale of radiation dermatitis,
- Patient-reported outcomes of radiation dermatitis using the PRO-CTCAE version 1.0, and
- Dermatologic-specific quality of life assessment
- To estimate the amount of KeraStat Cream used per patient and coverage on the skin.
- Conditions
- Head and Neck Cancer, Radiation Dermatitis
- Being tested
- KeraStat Cream, Routine Skin Care - Commercially Available Agents
- Medical subject headings
- Head and Neck Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeraStat CreamDevice
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 - Commercially Available AgentsOther
Also called Aveeno Skin Relief lotion, Eucerin, Lubriderm, Calendula cream or gel
Commercially available skin moisturizers from an approved list that do not interfere with radiation.
| Study group | Role | What they receive |
|---|---|---|
| KeraStat Skin Cream Arm | Experimental | 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. Receives: Device: KeraStat Cream |
| Routine Skin Care Arm (RSC Arm) | Active comparator | 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. Receives: Other: Routine Skin Care - Commercially Available Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate of Use of KeraStat Cream
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.
Measured: Up to 1 month post treatment with radiation therapy (6-7 weeks)
Secondary outcomes (5)
Number of Participants Discontinuing Skin Care Regimen
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.
Measured: Up to 1 month post treatment with radiation therapy (6-7 weeks)
Number of Participants With Grade 2+ Radiation Dermatitis
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.
Measured: Up to 1 month post treatment with radiation therapy (6-7 weeks)
Number of Participants Reporting Radiation Skin Reaction
Patient-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.
Measured: Up to 1 month post treatment with radiation therapy
Dermatology Life Quality Index Questionnaire
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.
Measured: At weeks 1-6 and up to 1 month post treatment with radiation therapy
Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage
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.
Measured: Up to 1 month post treatment with radiation therapy (7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start27 Jul 2020
- Primary completion6 Apr 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- KeraNetics, LLC, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ryan Hughes, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173247
- Sponsor's protocol ID
- IRB00062012
- Other IDs
- WFBCCC 97319, P30CA012197
- Status last verified
- Mar 2025
- First submitted
- 20 Nov 2019
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of KeraStat® Cream for Radiation Dermatitis During Head and Neck Radiotherapy
- ClinicalTrials.gov ID
- NCT04173247
- Acronym / sponsor ID
- IRB00062012
- Conditions
- Head and Neck Cancer, Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- KeraNetics, LLC, National Cancer Institute (NCI)
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Posted 7 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck.
Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.
Detailed description
Primary Objective(s)
- To determine the feasibility of the use of KeraStat Cream in patients receiving radiotherapy for head and neck cancer.
Secondary Objective(s)
- To determine the tolerability of KeraStat Cream in patients receiving radiotherapy for head and neck cancer compared to routine skin care.
- To assess the effectiveness of KeraStat Cream in reducing the severity of EASR in patients receiving radiotherapy for head and neck cancer, compared to routine skin care. This will be performed by evaluating:
- Objective evaluation of EASR using the CTCAE Version 5.0 scale of radiation dermatitis,
- Patient-reported outcomes of radiation dermatitis using the PRO-CTCAE version 1.0, and
- Dermatologic-specific quality of life assessment
- To estimate the amount of KeraStat Cream used per patient and coverage on the skin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KeraStat Skin Cream Arm | Experimental | Device: KeraStat CreamPatients 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. |
| Routine Skin Care Arm (RSC Arm) | Active comparator | Other: Routine Skin Care - Commercially Available AgentsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of head and neck cancer planned to receive conventionally-fractionated definitive radiotherapy to the head and neck to a total prescribed dose of at least 60 Gy
- Able and willing to sign protocol consent form
- Able and willing to complete tolerability and quality of life assessments
- Able and willing to have photographs of the affected area taken regularly
Key exclusion criteria (5 listed)
- Women who are pregnant, lactating/nursing or plan to become pregnant
- Previous radiation therapy to the area to be treated with radiation therapy
- Active, medically necessary use of topical corticosteroids in the irradiation area
- Active scleroderma or lupus requiring systemic medication
- Treatment with anti-EGFR antibodies for head and neck cancer (previously or planned)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KeraStat CreamKeraStat 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. | Device | KeraStat Skin Cream Arm |
| Routine Skin Care - Commercially Available AgentsAlso: Aveeno Skin Relief lotion, Eucerin, Lubriderm, Calendula cream or gelCommercially available skin moisturizers from an approved list that do not interfere with radiation. | Other | Routine Skin Care Arm (RSC Arm) |
Primary outcome
Completion Rate of Use of KeraStat Cream
Time frame: 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.
5 secondary outcomes
Number of Participants Discontinuing Skin Care Regimen
Time frame: Up to 1 month post treatment with radiation therapy (6-7 weeks)
Number of Participants With Grade 2+ Radiation Dermatitis
Time frame: Up to 1 month post treatment with radiation therapy (6-7 weeks)
Number of Participants Reporting Radiation Skin Reaction
Time frame: Up to 1 month post treatment with radiation therapy
Dermatology Life Quality Index Questionnaire
Time frame: At weeks 1-6 and up to 1 month post treatment with radiation therapy
Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage
Time frame: Up to 1 month post treatment with radiation therapy (7 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Hughes, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KeraStat Cream and Routine Skin Care - Commercially Available Agents in people with Head and Neck Cancer and Radiation Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate of Use of KeraStat Cream (time frame: Up to 1 month post treatment with radiation therapy (6-7 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.