Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

Completed · Not applicable

Conditions studied: Head and Neck Cancer, Radiation Dermatitis

In brief

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.

Key facts

Study ID: NCT04173247
Run by: Wake Forest University Health Sciences
People needed: 28
Starts: 2020-07-27
Expected to finish: 2022-10-07
Last updated by the study team: 2025-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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