The DOI matches its Crossref record; 49 of the 49 references it cites were found in a registry or an index.
Keratin-based topical cream for radiation dermatitis during head and neck radiotherapy: a randomised, open-label pilot study
Open accessAbstract
Introduction: Radiation dermatitis (RD) is a frequent toxicity during radiotherapy (RT) for head and neck cancer (HNC). We report the first use of KeraStat® Cream (KC), a topical, keratin-based wound dressing, in patients with HNC receiving RT. Methods: This pilot study randomized HNC patients treated with definitive or postoperative RT (≥60 Gy) to KC or standard of care (SOC), applied at least twice daily during and for 1-month after RT. Outcomes of interest included adherence to the assigned regimen (at least 10 applications per week of treatment), clinician- and patient-reported RD, and skin-related quality of life. Results: 24 patients were randomized and completed the study. Most patients had stage III-IV disease and oropharynx cancer. Median RT dose was 68 Gy; the bilateral neck was treated in 19 patients, and 18 patients received concurrent chemotherapy. Complete adherence was observed in 7/12 (SOC) vs. 10/12 (KC, p = 0.65). Adherence by patient-week was 61/68 versus 64/67, respectively (p = 0.20). No differences in RD were observed between groups. Conclusion: A randomized trial of KC versus SOC in HNC patients treated with RT is feasible with good adherence to study agent. An adequately powered randomized study is warranted to test the efficacy of KC in reducing RD.
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Saul, J. M., Bohnert, J. S., O’Brien, M., Alnuaimi, S., Carnwath, T. P., Dunivan, Q., Coffin, D. W., & Smith, T. L. (2025) · Tissue Engineering and Regenerative Medicine · doi:10.1007/s13770-025-00747-4 · Cited by 3
“Keratin materials have received U.S. FDA approval for radiation dermatitis via the 510 k mechanism and have been used in human trials [35], suggesting a viable path to the clinic for bone applications.”
Metadata
- Authors
- Hughes, R. T., Levine, B. J., Frizzell, B. A., Greven, K. M., Porosnicu, M., Lycan, T. W., Burnett, L. R., & Winkfield, K. M.
- Affiliations
- Wake Forest University Health Sciences (US)
- Wake Forest University (US)
- KeraNetics (United States) (US)
- Vanderbilt University Medical Center (US)
- Corresponding author
- Hughes, Ryan T
- ORCID
- Venue
- Journal of Radiotherapy in Practice
- Publisher
- Cambridge University Press (CUP)
- Published
- 2024
- Volume
- 23
- ISSN
- 1460-3969 (ISSN-L)
- 1467-1131
- PMC
- PMC11449460
- OpenAlex
- W4394813419
- Cited by
- 6
- References
- 49
- Citations by year
- 2026: 4 · 2025: 2
- FWCI
- 2.45
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Journal of Radiotherapy in Practice (publishedVersion, cc-by)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion, cc-by)
- Funders
- Wake Forest University (P30 CA012197, UG1CA189824)
- Comprehensive Cancer Center at Wake Forest Baptist Medical Center (P30CA012197)
- National Cancer Institute (UG1CA189824, P30CA012197, R01CA262041)
- Topics
- Health Sciences › Medicine › Dermatology › Chemotherapy-related skin toxicity
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Effects of Radiation Exposure
- Health Sciences › Dentistry › General Dentistry › Oral health in cancer treatment
- Keywords
- radiation dermatitis, head and neck cancer, topical cream, radiotherapy toxicity, skin-related quality of life, medication adherence, oropharyngeal cancer, neck irradiation
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