NCT04173247

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Radiation Dermatitis

Interventions

Type	Name	Description
DEVICE	KeraStat Cream	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.
OTHER	Routine Skin Care - Commercially Available Agents	Commercially available skin moisturizers from an approved list that do not interfere with radiation.

Timeline

• Start date: 2020-07-27
• Primary completion: 2022-04-06
• Completion: 2022-10-07
• First posted: 2019-11-21
• Last updated: 2025-03-17
• Results posted: 2023-09-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study