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Moisturizer

KeraStat Cream for Head and Neck Cancers

N/A
Waitlist Available
Led By Karen M Winkfield, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month post treatment with radiation therapy (6-7 weeks)
Awards & highlights

Study Summary

This trial is testing a new cream to see if it helps manage side effects from radiation therapy for head and neck cancer.

Eligible Conditions
  • Head and Neck Cancers
  • Radiation Skin Damage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month post treatment with radiation therapy (6-7 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month post treatment with radiation therapy (6-7 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Completion Rate of Use of KeraStat Cream
Secondary outcome measures
Dermatology Life Quality Index Questionnaire
Number of Participants Discontinuing Skin Care Regimen
Number of Participants Reporting Radiation Skin Reaction
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KeraStat Skin Cream ArmExperimental Treatment1 Intervention
Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Group II: Routine Skin Care Arm (RSC Arm)Active Control1 Intervention
Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KeraStat Cream
2020
N/A
~30

Find a Location

Who is running the clinical trial?

KeraNetics, LLCIndustry Sponsor
3 Previous Clinical Trials
77 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,978 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,239 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy
2020. "Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04173247.
~6 spots leftby Apr 2025
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