KeraStat(R) Cream for Radiation Dermatitis

Pilot Study: KeraStat(R) Cream for Radiation Dermatitis

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

Study Overview

• Status: Completed
• Conditions: Radiation Dermatitis
• Intervention / Treatment: Other: Standard of care; Device: KeraStat(R) Cream

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age 18 to 70
2. Female
3. Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
4. Able and willing to sign protocol consent form
5. Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
6. Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria:

1. Women who are pregnant, lactating/nursing or plan to become pregnant
2. Previous radiation therapy to the area to be treated with radiation therapy
3. Receiving palliative radiation therapy
4. Unhealed or infected surgical sites in the irradiation area
5. Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
6. Use of oral corticosteroids or topical corticosteroids in the irradiation area
7. Autoimmune disease
8. Skin disease in target irradiation area
9. Known allergy to the standard of care or ingredients in KeraStat Cream

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Standard of care; Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care	Other: Standard of care; Patients will be instructed to follow institutional standard of care for radiation dermatitis
EXPERIMENTAL: KeraStat Cream; Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.	Device: KeraStat(R) Cream; KeraStat Cream is a cream wound dressing that contains 5% keratin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Therapy Oncology Group Skin Toxicity Scoring	The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point.	Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.
Dermatology Life Quality Index	The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups.	Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Evaluate safety and tolerability of application of KeraStat Cream through comparison of adverse events reported in KeraStat Cream group versus standard of care.	Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.

Collaborators and Investigators

• Sponsor: KeraNetics, LLC
• Investigators: Principal Investigator: Karen Winfield, MD PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2018
• Primary Completion (ACTUAL): November 6, 2018
• Study Completion (ACTUAL): November 6, 2018

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (ACTUAL): June 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis
• Other Study ID Numbers: KSCM-CRD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes