NCT03374995

Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

Pilot Study: KeraStat Cream for Radiation Dermatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in patients with breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine a preliminary estimate of the improvement of skin's natural barrier, decrease of dehydration, and reduction in the appearance of inflammation associated with radiation therapy (RT) skin toxicity as well as patients' satisfaction with their skin after the application of the medical device topical keratin (KeraStat Cream) during RT in breast cancer patients. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive topical keratin topically at least twice daily (BID) until the end of radiation therapy (approximately 3-6 weeks). GROUP II: Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). After completion of study treatment, patients are followed up at 4-6 weeks.

Conditions

• Breast Carcinoma
• Radiation-Induced Dermatitis

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
OTHER	Quality-of-Life Assessment	Ancillary studies
DEVICE	Topical Keratin	Given topically

Timeline

• Start date: 2018-03-26
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2017-12-15
• Last updated: 2024-06-11
• Results posted: 2020-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study