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NCT Number: NCT04173247

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

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.

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Key information

Conditions

Head and Neck Cancer Dermatitis Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiation Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Routine Skin Care - Commercially Available Agents

Other

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

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

Primary outcomes

  1. Completion Rate of Use of KeraStat Cream

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

    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.

Secondary outcomes

  1. Number of Participants Discontinuing Skin Care Regimen

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

    Tolerability is measured by the number of patients who discontinue skin care regimen due to intolerance for any reason. In each arm, a 95% confidence interval will be calculated around the estimate of tolerability.

  2. Number of Participants With Grade 2+ Radiation Dermatitis

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

    Objective assessment of early adverse skin reaction defined as Grade 2+ using the CTCAE version 5.0 scale of radiation dermatitis will be compared between the KeraStat group and the RSC group at the end of treatment, using a Fisher's exact test.

  3. Number of Participants Reporting Radiation Skin Reaction

    Time frame: Up to 1 month post treatment with radiation therapy

    Patient-reported assessment of skin toxicity using the PRO-CTCAE version 1.0 scale of radiation skin symptoms (skin dryness, itching, radiation skin reaction and skin darkening). Score scale is none to very severe and Yes or No for skin darkening.

  4. Dermatology Life Quality Index Questionnaire

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

    A 10-item questionnaire to measure how skin problems have affected participants' lives. Scoring for each question ranges from 0-3 with very much scored as 3 and not at all or not relevant score as 0. The DLQI is calculated by summing the score of each questions resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. The mean of the highest DLQI score across all time points will be compared between the KeraStat and RSC groups using a t-test.

  5. Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage

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

    Skin coverage is defined as the total number of tubes of KeraStat Cream used over 7 weeks OVER ALL participants in the KeraStat arm only.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • KeraNetics, LLC
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 21, 2019
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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