KeraStat Cream for Radiation Dermatitis in Head and Neck Cancer

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Topical corticosteroids, Anti-EGFR biologics

Disqualifiers: Early stage cancer, Previous radiation, Scleroderma, Lupus, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cream, KeraStat, to determine its effectiveness in treating skin rashes caused by radiation in individuals with head and neck cancer. Researchers use a mobile app, MyCap, to collect information from participants about their skin condition. Individuals diagnosed with head and neck cancer and scheduled for a specific type of radiation treatment might be suitable for this trial. Participants must be comfortable using a smartphone app to report their symptoms.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance skin care for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use topical corticosteroids on the radiation area or have active lupus requiring systemic medication. If you're on anti-EGFR therapy, you cannot participate.

What prior data suggests that the MyCap mobile application is safe for collecting patient information?

Research shows that KeraStat Cream helps with skin problems caused by radiation treatment. Studies have used this cream to aid healing by keeping the skin moist, which is crucial for recovery.

Users of KeraStat Cream have generally tolerated it well. No major reports of serious side effects suggest it is safe for those undergoing radiation therapy. However, individual reactions can differ, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about KeraStat Cream for radiation dermatitis in head and neck cancer patients because it offers a new approach to soothing and healing the skin. Unlike standard treatments like corticosteroid creams or emollients, KeraStat Cream uses a unique keratin-based formula. This innovative ingredient is thought to enhance the skin's natural repair processes, potentially reducing inflammation and promoting faster recovery. By offering a different mechanism of action, KeraStat Cream could provide more effective relief for patients suffering from the uncomfortable side effects of radiation therapy.

What evidence suggests that KeraStat Cream might be an effective treatment for radiation dermatitis?

Studies have shown that KeraStat Cream, a keratin-based skin treatment, can aid in healing skin affected by radiation therapy. Research indicates that it forms a protective layer on the skin, promoting the healing of small wounds and reducing skin damage. In this trial, participants will use KeraStat Cream during radiation treatment. Early findings suggest it might effectively manage skin problems caused by radiation, particularly for those undergoing treatment for head and neck cancer. Patients who used KeraStat Cream reported milder skin reactions compared to those receiving standard care. ^{1 3 4 6 7}

Who Is on the Research Team?

Ryan Hughes, M.D.

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with head and neck cancers who are undergoing radiation therapy and experiencing radiation dermatitis, a type of skin rash. Participants should be willing to use the MyCap app to report on their condition.

Inclusion Criteria

Ability to understand and the willingness to sign an IRB-approved informed consent document in English

Able and willing to complete electronic toxicity and quality of life assessments in the MyCap application using their personal mobile device

I have a clinical diagnosis of head and neck cancer without a confirmed pathology.

Exclusion Criteria

I have early-stage vocal cord cancer and will be treated with targeted radiation only.

I have had radiation therapy on my head or neck before.

I have scleroderma or lupus and need medication for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive radiation therapy for head and neck cancer while using KeraStat cream to assess radiation dermatitis

Up to 2 years

Weekly visits during radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy, including weekly assessments for 4 weeks post-therapy

4 weeks

Weekly visits for 4 weeks post radiation therapy

Patient Engagement and Satisfaction Assessment

Participants engage with the MyCap app for data collection and provide feedback on satisfaction with the M-PART framework

4 weeks after completion of radiation therapy

What Are the Treatments Tested in This Trial?

Interventions

• KeraStat Cream

Trial Overview The study tests KeraStat cream's effectiveness in treating acute radiation dermatitis. It involves clinical assessments, using the cream, reporting symptoms via MyCap app, and providing feedback through a phone interview.

How Is the Trial Designed?

Group I: M-PART Assessment via MyCap Experimental Treatment 4 Interventions

Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11449460/

Keratin-based topical cream for radiation dermatitis during ... We report the first use of KeraStat ® Cream (KC), a topical, keratin-based wound dressing, in patients with HNC receiving RT.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04173247

Study of KeraStat Cream for Radiation Dermatitis During ... This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine ...

3. redjournal.org redjournal.org/article/S0360-3016(23)06373-3/fulltext

Feasibility of a Keratin-Based Topical Cream for Radiation ... KeraStat Cream (KC), an emulsion-based wound dressing that acts as a protective barrier that promotes the healing of minor skin wounds and partial-thickness ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38186361/

Randomized Pilot Study of a Keratin-based Topical Cream for ... The purpose of this study was to evaluate the feasibility of using a keratin-based topical cream, KeraStat® Cream (KC; KeraNetics, Inc., Winston Salem, NC, USA) ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/15330338231222137

Randomized Pilot Study of a Keratin-based Topical Cream ... The purpose of this study was to evaluate the feasibility of using a keratin-based topical cream, KeraStat® Cream (KC; KeraNetics, Inc., Winston ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03559218

NCT03559218 | KeraStat(R) Cream for Radiation Dermatitis 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 ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K192386.pdf

July 16, 2020 KeraNetics Luke Burnett CEO and CSO 200 ... Both devices share the same mode of action in that they provide a moist environment to support wound healing, including wounds due to radiation ...