Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900258
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-05-10
Brief Title:
Tirbanibulin 1 Ointment for the Treatment of Chronically Sun-damaged Skin on the Face
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Tirbanibulin 1 Ointment for the Treatment of Chronically Sun-damaged Skin on the Face
Status:
COMPLETED
Status Verified Date:
2023-11
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:
SunDamage
Brief Summary:
Interventional monocentric national single-arm uncontrolled open prospective phase IV study Since this study is not powered for confirmative testing analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days according to the SmPC Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA Safety and efficacy are assessed at end of treatment visit EoT approximately 3 days after the last dose ie day 8 2 and at a follow-up visit FuV 57 7 d after the start of the treatment UV images Canfield VISIA will be taken at baseline EoT and FuV accompanied by conventional dermatological assessment according to clinical routine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None