Radiation DermatitisNCT06441266
M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis
A study testing KeraStat cream, M-PART Assessments via MyCap and Clinical Assessments in people with Radiation Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to test the ability of a mobile device application (MyCap) to collect patient information about their radiation skin rash in patients with head and neck cancer being treated with radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- KeraStat cream, M-PART Assessments via MyCap and Clinical Assessments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2025to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Histological or cytological diagnosis of head and neck cancer (of any part of the oral cavity, pharynx, larynx, or sinuses) planned to receive conventionally fractionated radiation therapy (RT) targeting the head and neck to a total prescribed dose of at least 50 Gy. The 50 Gy radiation therapy target must include at least a part of the unilateral and/or bilateral lymph node regions of the head/neck. Planned prescribed dose will be reviewed and approved by the study principal investigator.
- NOTE: Patients without a clear pathologic diagnosis of invasive disease (i.e., biopsy showing at least carcinoma in situ) but with clinically diagnosed head and neck cancer planned for treatment as above are also eligible.
- Age ≥ 18 years at the time of enrollment.
- Able and willing to complete electronic toxicity and quality of life assessments in the MyCap application using their personal mobile device.
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative) in English.
Who cannot join
- Early stage (Stage I-II) squamous cell carcinoma of the glottic larynx planned for treatment with limited field radiation therapy alone. These participants are excluded since they are expected to receive a more limited exposure to radiation therapy.
- Patients planned for treatment to the primary site alone without regional lymph node targeting.
- Previous radiation therapy to the area in the head and neck to be treated with radiation therapy.
- Active use of topical corticosteroids in the irradiation area at the time of enrollment. Note that it is acceptable to use topical corticosteroids if study participants develop moist desquamation during radiation therapy.
- History of scleroderma or active lupus requiring systemic medication at the time of enrollment.
- Planned concurrent treatment with anti-EGFR biologic therapy (e.g., cetuximab) for head and neck cancer.
- Individuals who are pregnant or plan to become pregnant. Radiotherapy is contraindicated in this patient population.
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 Multi-platform Assessment of Radiation Toxicity (M-PART) in Head and Neck Cancer Patients Treated With KeraStat® Cream for Acute Radiation Dermatitis
The purpose of this research study is to test the ability of a mobile device application (MyCap) to collect patient information about their radiation skin rash in patients with head and neck cancer being treated with radiation therapy.
Read the detailed description
Primary Objective: To determine the feasibility of M-PART for the assessment of acute radiation dermatitis in patients treated with radiotherapy for head and neck cancer via MyCap.
Secondary Objectives:
- To assess agreement between site clinician-rated CTCAE G2+ radiation dermatitis with moist desquamation and patient-reported moist desquamation (a and b above).
- To assess the proportion of patient-submitted photographs of skin in the irradiated area that are evaluable for radiation dermatitis assessments by central review.
- To assess agreement between clinician-rated radiation dermatitis grading, central review of patient-submitted photographs, and central review of standardized clinic photographs (methods a, c, and d above).
- To measure the level of interval (i.e., optional engagement in between scheduled collection) patient engagement in the collection of radiation toxicity outcomes using the M-PART methodology.
- To measure patient and research staff satisfaction, perceptions, and preferences with regard to the M-PART data collection framework.
OUTLINE:
Patients apply KeraStat topically at least twice daily (BID) or more as needed and complete MyCap patient reported dermatitis assessments and submit photographs in MyCap once a week (QW) during RT and for 1 month following treatment in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo clinician skin rash assessments and standardized in-clinic photography on study.
After completion of study intervention, patients may be followed for up to 6 months.
- Conditions
- Radiation Dermatitis
- Being tested
- KeraStat cream, M-PART Assessments via MyCap, Clinical Assessments, Feedback phone interview
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeraStat creamDrug
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. The intervention is a topical cream applied at least twice daily starting at start of radiation therapy until 1-month from the end of radiation therapy completion
M-PART Assessments via MyCapDevice
The M-PART approach harnesses the remote data collection capabilities of MyCap to facilitate remote collection or data including but not limited to toxicity assessments, quality of life surveys, and patient-provided photographs of the skin in the treated area
Clinical AssessmentsOther
Participants will undergo assessments at baseline (prior to radiation therapy start), weekly during and after radiation therapy until 1-month post-radiation therapy. Medical history will be collected at baseline including primary cancer site, HPV status (if oropharyngeal cancer primary), laterality, TNM classification, stage, surgical resection prior to radiation therapy, weight, body mass index and patient self-reported Fitzpatrick skin phototype.
Feedback phone interviewOther
Participant satisfaction, perceptions and preferences with using M-PART will be discussed.
| Study group | Role | What they receive |
|---|---|---|
| M-PART Assessment via MyCap | Experimental | Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream. Receives: Drug: KeraStat cream; Device: M-PART Assessments via MyCap; Other: Clinical Assessments; Other: Feedback phone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility
Participants to complete 75% or more of required assessments over the course of the study will be calculated in two steps. First, investigators will separate patients into two groups, those who have completed 75% or more of their scheduled assessments over all time periods, and those who have not. Investigators will then divide the former number by the total number of patients who completed the study (i.e., completed their radiation treatment) with a final anticipated analyzable number of 16, using a 95% confidence interval. Thus, if 50% or more of the patients in the sample have completed at least 75% of scheduled assessments, the study will be deemed feasible to conduct a future study using M-PART.
Measured: 4 weeks post radiation therapy, up to 2 years
Secondary outcomes (6)
Number of Participants to Self-Report Presence of Radiation Dermatitis Compared to Site Clinician Reported Radiation Dermatitis.
To measure agreement between site clinician reported grade 2+ radiation dermatitis with moist desquamation (yes/no) and patient-reported moist desquamation (any/none) at each weekly visit, investigators will use McNemar's test, which tests the null hypothesis that there is no difference between site clinician-reported and patient-reported presence of moist desquamation. Investigators will also estimate sensitivity and specificity (relative to the gold standard site clinician report) of the participant's self-reported moist desquamation yes/no. We will also examine whether agreement appears to vary meaningfully by week.
Measured: At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years
Percentage of Participant-Submitted Photographs Evaluable for Radiation Dermatitis Grading
The number of scheduled patient-submitted photographs (submitted through MyCap as part of the scheduled/required assessments) that are evaluable (if the central reviewer is able to provide a radiation dermatitis grade) in at least two different ways. First, in the most straightforward calculation, investigators will use as the denominator the total number of patient-submitted photographs that were scheduled, with the numerator being the number of photographs that are able to be graded for radiation dermatitis by a central reviewer. Second, to examine the possibility of intra-person correlation in evaluable photographs, investigators will compute for each individual patient the proportion of their photographs that were deemed evaluable and examine the distribution of these individual-level proportions in the sample. Finally, we will also carry out the above two calculations considering all photographs (scheduled and interval).
Measured: At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years
Proportion of Agreement in Grading Methods for Radiation Dermatitis
To assess agreement between the three different methods of grading (clinician-rated radiation dermatitis grading, participant-submitted photographs and standardized clinic photographs) investigators will compare two methods at a time in a contingency table and estimate proportion agreeing by focusing on the diagonal where ratings of grade were identical. Investigators will also dichotomize the ordinal grades into grade 2+ yes/no and compute McNemar's test for each dichotomous comparison of ratings. Finally, investigators will also compute measures of sensitivity and specificity regarding grade 2+ yes/no again considering site clinician ratings as the gold standard.
Measured: At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years
Number of Skin Assessments Provided Through MyCap - Patient Engagement
To measure the level of patient engagement in the interval collection of radiation dermatitis outcomes, investigators will estimate the proportion of the total samples who provide any (yes vs no) interval assessment information through MyCap, and will also examine the frequency distribution of the number of such interval assessments provided among the whole sample. Additionally, investigators will make the denominator more specific by utilizing the question on the weekly scheduled patient-reported outcomes form that asks patients if they have noticed the starting or ending of moist desquamation in the interval between clinical visits, and examine what proportion of patients who answer yes on this question sent in interval information (pictures, patient-reported outcomes) during the relevant interval.
Measured: At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years
Frequency in Responses to Satisfaction with M-PART - Semi-Quantitative Survey
The analysis of patient satisfaction, perceptions and preferences will depend on the measure of collection. For the semi-quantitative survey, investigators will compile simple descriptive statistics showing frequencies and proportions of participants in each category of response to each question.
Measured: 4 weeks after completion of radiation therapy, up to 2 years
Frequency in Responses to Satisfaction with M-PART - Qualitative Interviews
For the qualitative interviews of patients and staff, investigators will analyze the transcripts using a thematic analysis approach. Trained qualitative researchers will review the interview transcripts and use a combined inductive-deductive approach to develop a codebook of concepts important to patient and staff satisfaction and experience with M-PART. Codes will be applied to data in a multifunctional data management and analysis software, and the codebook will be revised as needed during the analysis to best categorize and interpret the data. All transcripts will be independently coded by two researchers, and coding discrepancies will be discussed and resolved iteratively. Segments of text will be abstracted by code or groups of codes, summarized, and synthesized into themes.
Measured: 4 weeks after completion of radiation therapy, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start8 May 2025
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ryan T Hughes, MD, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441266
- Sponsor's protocol ID
- IRB00115715
- Other IDs
- P30CA012197, ONC-HN-2404
- Status last verified
- Jun 2026
- First submitted
- 29 May 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Multi-platform Assessment of Radiation Toxicity (M-PART) in Head and Neck Cancer Patients Treated With KeraStat® Cream for Acute Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT06441266
- Acronym / sponsor ID
- IRB00115715
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 May 2025 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the ability of a mobile device application (MyCap) to collect patient information about their radiation skin rash in patients with head and neck cancer being treated with radiation therapy.
Detailed description
Primary Objective: To determine the feasibility of M-PART for the assessment of acute radiation dermatitis in patients treated with radiotherapy for head and neck cancer via MyCap.
Secondary Objectives:
- To assess agreement between site clinician-rated CTCAE G2+ radiation dermatitis with moist desquamation and patient-reported moist desquamation (a and b above).
- To assess the proportion of patient-submitted photographs of skin in the irradiated area that are evaluable for radiation dermatitis assessments by central review.
- To assess agreement between clinician-rated radiation dermatitis grading, central review of patient-submitted photographs, and central review of standardized clinic photographs (methods a, c, and d above).
- To measure the level of interval (i.e., optional engagement in between scheduled collection) patient engagement in the collection of radiation toxicity outcomes using the M-PART methodology.
- To measure patient and research staff satisfaction, perceptions, and preferences with regard to the M-PART data collection framework.
OUTLINE:
Patients apply KeraStat topically at least twice daily (BID) or more as needed and complete MyCap patient reported dermatitis assessments and submit photographs in MyCap once a week (QW) during RT and for 1 month following treatment in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo clinician skin rash assessments and standardized in-clinic photography on study.
After completion of study intervention, patients may be followed for up to 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M-PART Assessment via MyCap | Experimental | Drug: KeraStat cream, Device: M-PART Assessments via MyCap, Other: Clinical Assessments, Other: Feedback phone interviewAssessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or cytological diagnosis of head and neck cancer (of any part of the oral cavity, pharynx, larynx, or sinuses) planned to receive conventionally fractionated radiation therapy (RT) targeting the head and neck to a total prescribed dose of at least 50 Gy. The 50 Gy radiation therapy target must include at least a part of the unilateral and/or bilateral lymph node regions of the head/neck. Planned prescribed dose will be reviewed and approved by the study principal investigator.
- NOTE: Patients without a clear pathologic diagnosis of invasive disease (i.e., biopsy showing at least carcinoma in situ) but with clinically diagnosed head and neck cancer planned for treatment as above are also eligible.
- Age ≥ 18 years at the time of enrollment.
- Able and willing to complete electronic toxicity and quality of life assessments in the MyCap application using their personal mobile device.
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative) in English.
Key exclusion criteria (7 listed)
- Early stage (Stage I-II) squamous cell carcinoma of the glottic larynx planned for treatment with limited field radiation therapy alone. These participants are excluded since they are expected to receive a more limited exposure to radiation therapy.
- Patients planned for treatment to the primary site alone without regional lymph node targeting.
- Previous radiation therapy to the area in the head and neck to be treated with radiation therapy.
- Active use of topical corticosteroids in the irradiation area at the time of enrollment. Note that it is acceptable to use topical corticosteroids if study participants develop moist desquamation during radiation therapy.
- History of scleroderma or active lupus requiring systemic medication at the time of enrollment.
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. The intervention is a topical cream applied at least twice daily starting at start of radiation therapy until 1-month from the end of radiation therapy completion | Drug | M-PART Assessment via MyCap |
| M-PART Assessments via MyCapThe M-PART approach harnesses the remote data collection capabilities of MyCap to facilitate remote collection or data including but not limited to toxicity assessments, quality of life surveys, and patient-provided photographs of the skin in the treated area | Device | M-PART Assessment via MyCap |
| Clinical AssessmentsParticipants will undergo assessments at baseline (prior to radiation therapy start), weekly during and after radiation therapy until 1-month post-radiation therapy. Medical history will be collected at baseline including primary cancer site, HPV status (if oropharyngeal cancer primary), laterality, TNM classification, stage, surgical resection prior to radiation therapy, weight, body mass index and patient self-reported Fitzpatrick skin phototype. | Other | M-PART Assessment via MyCap |
| Feedback phone interviewParticipant satisfaction, perceptions and preferences with using M-PART will be discussed. | Other | M-PART Assessment via MyCap |
Primary outcome
Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility
Time frame: 4 weeks post radiation therapy, up to 2 years
Participants to complete 75% or more of required assessments over the course of the study will be calculated in two steps. First, investigators will separate patients into two groups, those who have completed 75% or more of their scheduled assessments over all time periods, and those who have not. Investigators will then divide the former number by the total number of patients who completed the study (i.e., completed their radiation treatment) with a final anticipated analyzable number of 16, using a 95% confidence interval. Thus, if 50% or more of the patients in the sample have completed at least 75% of scheduled assessments, the study will be deemed feasible to conduct a future study using M-PART.
6 secondary outcomes
Number of Participants to Self-Report Presence of Radiation Dermatitis Compared to Site Clinician Reported Radiation Dermatitis.
Time frame: At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years
Percentage of Participant-Submitted Photographs Evaluable for Radiation Dermatitis Grading
Time frame: At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years
Proportion of Agreement in Grading Methods for Radiation Dermatitis
Time frame: At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years
Number of Skin Assessments Provided Through MyCap - Patient Engagement
Time frame: At baseline, weekly during radiation therapy, 4 weeks post radiation therapy, up to 2 years
Frequency in Responses to Satisfaction with M-PART - Semi-Quantitative Survey
Time frame: 4 weeks after completion of radiation therapy, up to 2 years
Frequency in Responses to Satisfaction with M-PART - Qualitative Interviews
Time frame: 4 weeks after completion of radiation therapy, up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- 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 T Hughes, MD principal investigator
Wake Forest Baptist Comprehensive Cancer Center
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, M-PART Assessments via MyCap and Clinical Assessments in people with 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 5 inclusion and 7 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 6 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility (time frame: 4 weeks post radiation therapy, up to 2 years). 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 6 Jul 2026.