KeraStat(R) Cream for Radiation Dermatitis

Radiation Dermatitis Clinical Trial

Official title:

Pilot Study: KeraStat(R) Cream for Radiation Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559218
• Other study ID #: KSCM-CRD-001
• Status: Completed
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: November 6, 2018

Study information

• Verified date: September 2021
• Source: KeraNetics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
KeraNetics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.