CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
KeraStat Cream +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04173247
NCT04173247N/ACompleted
CompareCT.gov

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

Wake Forest University Health Sciences·interventional·Posted Nov 21, 2019·Updated Mar 17, 2025

In Brief

A clinical study evaluating KeraStat Cream and Routine Skin Care - Commercially Available Agents for Head and Neck Cancer and Radiation Dermatitis. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Radiation Dermatitis
CountriesUnited States
CollaboratorsKeraNetics, LLC, National Cancer Institute (NCI)

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 21, 2019
Enrollment StartJul 27, 2020
Primary CompletionApr 6, 2022
Study CompletionOct 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.6 years ago

Interventions

KeraStat Creamdevice

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 Agentsother

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