Related Experiment Video
Updated: Jul 6, 2025
11:39
The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis
Published on: July 11, 2013
39.0K
Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer Patients
Karen M Winkfield1,2, Ryan T Hughes2, Doris R Brown2
1Meharry-Vanderbilt Alliance, Nashville, TN, USA.
Technology in Cancer Research & Treatment
|January 8, 2024
Summary
KeraStat® Cream (KC) showed promise in managing radiation dermatitis (RD) for breast cancer patients undergoing radiotherapy (RT). The topical treatment was safe, well-tolerated, and demonstrated a trend towards reduced RD severity and improved quality of life.
Area of Science:
- Oncology
- Dermatology
- Clinical Trials
Background:
- Radiotherapy (RT) for breast cancer frequently causes radiation dermatitis (RD), a significant side effect impacting patient quality of life.
- Current management strategies for RD often involve standard of care (SOC) topical agents, with varying degrees of efficacy.
- There is a need for effective interventions to mitigate RT-induced skin toxicity in breast cancer patients.
Purpose of the Study:
- To evaluate the feasibility and preliminary efficacy of KeraStat® Cream (KC), a novel keratin-based topical formulation, for managing RD in breast cancer patients undergoing RT.
- To assess the safety, tolerability, and compliance of KC application.
- To compare RD severity and patient-reported quality of life between KC and SOC treatment groups.
Main Methods:
- A single-center, randomized, open-label study involving 24 breast cancer patients undergoing RT.
- Participants were assigned to apply either KC or SOC topical treatments twice daily throughout RT and for 30 days post-RT.
- Outcomes included compliance, safety, RD severity (Radiation Therapy Oncology Group scale), and quality of life (Dermatology Life Quality Index).
Main Results:
- KC was found to be safe and well-tolerated, with no reported adverse events.
- The KC group exhibited a lower rate of Grade 2 RD (30.8%) compared to the SOC group (54.5%).
- Patients using KC showed a trend towards lower mean RD scores and improved quality of life (Dermatology Life Quality Index) compared to the SOC group.
Conclusions:
- KeraStat® Cream (KC) is a safe and well-tolerated option for managing radiation dermatitis in breast cancer patients undergoing radiotherapy.
- While not powered for definitive efficacy conclusions, preliminary data suggest KC may reduce RD severity and improve patient quality of life.
- Further large-scale, powered clinical trials are warranted to confirm the efficacy of KC in managing radiation dermatitis.
