Completed

Pilot Study: KeraStat(R) Cream for Radiation Dermatitis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

KeraStat(R) Cream

+ Standard of care

DeviceOther
Who is being recruted

Dermatitis+3

+ Radiation Injuries

+ Radiodermatitis

From 18 to 70 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2018
See protocol details

Summary

Principal SponsorKeraNetics, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 11, 2018

Actual date on which the first participant was enrolled.

The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial. The secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin.

Official TitlePilot Study: KeraStat(R) Cream for Radiation Dermatitis
NCT03559218
Principal SponsorKeraNetics, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisRadiation InjuriesRadiodermatitisSkin DiseasesWounds and InjuriesSkin and Connective Tissue Diseases

Criteria

6 inclusion criteria required to participate
Age 18 to 70
Female
Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
Able and willing to sign protocol consent form
Show More Criteria
9 exclusion criteria prevent from participating
Women who are pregnant, lactating/nursing or plan to become pregnant
Previous radiation therapy to the area to be treated with radiation therapy
Receiving palliative radiation therapy
Unhealed or infected surgical sites in the irradiation area
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.

Group II

Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Wake Forest School of Medicine

Winston-Salem, United StatesOpen Wake Forest School of Medicine in Google Maps
CompletedOne Study Center