Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-26 @ 12:21 AM
Study NCT ID:
NCT03559218
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2018-03-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
KeraStat(R) Cream for Radiation Dermatitis
Sponsor:
KeraNetics, LLC
Organization:
Study Overview
Official Title:
Pilot Study: KeraStat(R) Cream for Radiation Dermatitis
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: