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

NCT04173247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-03-17

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • KeraNetics, LLC

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Ryan Hughes, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2022-04-06
Completion
2022-10-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04173247 on ClinicalTrials.gov