Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 9:14 AM
Study NCT ID:
NCT06319794
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2024-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis
Sponsor:
TORQUR
Organization:
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 and/or Scalp and/or Back of Hands Over a 2 and 4-week Treatment Period
Status:
COMPLETED
Status Verified Date:
2025-06
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 and/or scalp and/or 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 (1:1):
* 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 (1:1):
* Arm A: Topical bimiralisib gel treatment for 2 weeks
* Arm B: Topical bimiralisib gel treatment for 4 weeks
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: