Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 26
Summary
- Conditions
- Head and Neck Cancer
- Radiation Dermatitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ca...
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.
Tracking Information
- NCT #
- NCT04173247
- Collaborators
- KeraNetics, LLC
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Karen M Winkfield, MD, PhD Wake Forest University Health Sciences
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