KeraStat(R) Cream for Radiation Dermatitis

NCT03559218 | Completed Results FDA Device

• 1 other identifier: KSCM-CRD-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of Participants With Adverse Events

  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.

Study Arms (2)

Standard of care

OTHER

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

Other: Standard of care

KeraStat Cream

EXPERIMENTAL

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

Device: KeraStat(R) Cream

Interventions

KeraStat(R) Cream DEVICE

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

KeraStat Cream

Standard of care OTHER

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

Standard of care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
• Able and willing to have photographs of the affected area taken regularly

You may not qualify if:

• 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
• Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
• Use of oral corticosteroids or topical corticosteroids in the irradiation area
• Autoimmune disease
• Skin disease in target irradiation area
• Known allergy to the standard of care or ingredients in KeraStat Cream

Sponsors & Collaborators

• KeraNetics, LLC: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Radiodermatitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Ryan Clohessy, PhD
• Organization: KeraNetics

rclohessy@keranetics.com

4102513940

Study Officials

• Karen Winfield, MD PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: June 18, 2018
• Study Start: April 11, 2018
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: September 9, 2021
• Results First Posted: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)