MedTrace Logo

KeraStat(R) Cream for Radiation Dermatitis

NCT03559218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-09-09

Study results available
· View outcomes & findings →

Summary

The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.

Conditions

  • Radiation Dermatitis

Interventions

DEVICE

KeraStat(R) Cream

KeraStat Cream is a cream wound dressing that contains 5% keratin.

OTHER

Standard of care

Patients will be instructed to follow institutional standard of care for radiation dermatitis

Sponsors & Collaborators

  • KeraNetics, LLC

    lead INDUSTRY

Principal Investigators

  • Karen Winfield, MD PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2018-11-06
Completion
2018-11-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03559218 on ClinicalTrials.gov