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

Not Applicable
Completed
Conditions
Radiation Dermatitis
Head and Neck Cancer
Interventions
Device: KeraStat Cream
Other: Routine Skin Care - Commercially Available Agents
Registration Number
NCT04173247
Lead Sponsor
Wake Forest University Health Sciences
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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
28
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
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
KeraStat Skin Cream ArmKeraStat CreamPatients 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.
Routine Skin Care Arm (RSC Arm)Routine Skin Care - Commercially Available AgentsPatients 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.
Primary Outcome Measures
NameTimeMethod
Completion Rate of Use of KeraStat CreamUp 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 Outcome Measures
NameTimeMethod
Number of Participants With Grade 2+ Radiation DermatitisUp 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.

Number of Participants Discontinuing Skin Care RegimenUp 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.

Number of Participants Reporting Radiation Skin ReactionUp 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.

Dermatology Life Quality Index QuestionnaireAt 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.

Number of Tubes of KeraStat Cream Used to Calculate Skin CoverageUp 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.

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

🇺🇸

Winston-Salem, North Carolina, United States

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