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

NCT04173247 | Completed Results FDA Device

• 3 other identifiers: IRB00062012WFBCCC 97319P30CA012197
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer; Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• Completion Rate of Use of KeraStat Cream

  Feasibility of use of KeraStat Cream is measured by participant compliance with an average of 10 or more applications per week being classified as complaint. In each arm, a 95% confidence interval will be calculated around the estimate of compliance.

  Up to 1 month post treatment with radiation therapy (6-7 weeks)

Secondary Outcomes (5)

• Number of Participants Discontinuing Skin Care Regimen

  Up to 1 month post treatment with radiation therapy (6-7 weeks)

• Number of Participants With Grade 2+ Radiation Dermatitis

  Up to 1 month post treatment with radiation therapy (6-7 weeks)

• Number of Participants Reporting Radiation Skin Reaction

  Up to 1 month post treatment with radiation therapy

• Dermatology Life Quality Index Questionnaire

  At weeks 1-6 and up to 1 month post treatment with radiation therapy

• Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage

  Up to 1 month post treatment with radiation therapy (7 weeks)

Study Arms (2)

KeraStat Skin Cream Arm

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.

Device: KeraStat Cream

Routine Skin Care Arm (RSC Arm)

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.

Other: Routine Skin Care - Commercially Available Agents

Interventions

KeraStat Cream DEVICE

KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.

KeraStat Skin Cream Arm

Routine Skin Care - Commercially Available Agents OTHER

Commercially available skin moisturizers from an approved list that do not interfere with radiation.

Also known as: Aveeno Skin Relief lotion, Eucerin, Lubriderm, Calendula cream or gel, Aloe vera gels, Cetaphil, CeraVe, Petroleum based with mineral oil ointments: Aquaphor, Balmex, Elta

Routine Skin Care Arm (RSC Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• KeraNetics, LLC: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiodermatitis

Interventions

eucerin; Gels; cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion; Zinc Oxide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

jkettler@wakehealth.edu

336-716-4760

Study Officials

• Ryan Hughes, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 21, 2019
• Study Start: July 27, 2020
• Primary Completion: April 6, 2022
• Study Completion: October 7, 2022
• Last Updated: March 17, 2025
• Results First Posted: September 7, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)