KeraStat(R) Cream for Radiation Dermatitis

Completed · Not applicable

Conditions studied: Radiation Dermatitis

In brief

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

Key facts

Study ID

NCT03559218

Run by

KeraNetics, LLC

People needed

25

Starts

2018-04-11

Expected to finish

2018-11-06

Last updated by the study team

2021-09-09

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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