Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319794
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-06
Brief Title:
Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis
Sponsor:
TORQUR
Organization:
TORQUR
Study Overview
Official Title:
A Randomized Phase 2 Proof-of-Concept Study to Evaluate the Efficacy and Safety of Topical Bimiralisib Application in Participants Suffering From Actinic Keratosis on the Face andor Scalp andor Back of Hands Over a 2 and 4-week Treatment Period
Status:
RECRUITING
Status Verified Date:
2024-03
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 aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis AK on the face andor scalp andor back of hands
Detailed Description:
This is a multi-center randomized open label parallel group study The study products will be applied to the target lesions for a duration of 2 or 4 weeks of treatment
The study consists of the following periods
Screening up to 30 days
Treatment 2 or 4 weeks
Follow-Up 4 weeks
Participants will be randomized to one of two groups 11
Arm A Topical bimiralisib gel treatment for 2 weeks
Arm B Topical bimiralisib gel treatment for 4 weeks
The study consists of the following periods
Screening up to 30 days
Treatment 2 or 4 weeks
Follow-Up 4 weeks
Participants will be randomized to one of two groups 11
Arm A Topical bimiralisib gel treatment for 2 weeks
Arm B Topical bimiralisib gel treatment for 4 weeks
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