Completed

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

What is being tested

KeraStat Cream

+ Routine Skin Care - Commercially Available Agents

DeviceOther

Who is being recruted

Dermatitis+6

+ Head and Neck Neoplasms

+ Neoplasms

Over 18 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional

Study Start: July 2020

See protocol details

Summary

Principal SponsorWake Forest University Health Sciences

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 27, 2020

Actual date on which the first participant was enrolled.

Primary Objective(s) • To determine the feasibility of the use of KeraStat Cream in patients receiving radiotherapy for head and neck cancer. Secondary Objective(s) * To determine the tolerability of KeraStat Cream in patients receiving radiotherapy for head and neck cancer compared to routine skin care. * To assess the effectiveness of KeraStat Cream in reducing the severity of EASR in patients receiving radiotherapy for head and neck cancer, compared to routine skin care. This will be performed by evaluating: * Objective evaluation of EASR using the CTCAE Version 5.0 scale of radiation dermatitis, * Patient-reported outcomes of radiation dermatitis using the PRO-CTCAE version 1.0, and * Dermatologic-specific quality of life assessment * To estimate the amount of KeraStat Cream used per patient and coverage on the skin.

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

NCT04173247

Principal SponsorWake Forest University Health Sciences

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisHead and Neck NeoplasmsNeoplasmsNeoplasms by SiteRadiation InjuriesRadiodermatitisSkin DiseasesWounds and InjuriesSkin and Connective Tissue Diseases

Criteria

4 inclusion criteria required to participate

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

5 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.

Group II

Active Comparator

Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, United StatesOpen Wake Forest Baptist Comprehensive Cancer Center in Google Maps

CompletedOne Study Center