NCT03559218

KeraStat(R) Cream for Radiation Dermatitis

Pilot Study: KeraStat(R) Cream for Radiation Dermatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: KeraNetics, LLC · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-04-11
• Primary completion: 2018-11-06
• Completion: 2018-11-06
• First posted: 2018-06-18
• Last updated: 2021-09-09
• Results posted: 2021-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study