NCT06319794

Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: TORQUR · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Bimiralisib	Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks
DRUG	Bimiralisib	Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 4 weeks

Timeline

• Start date: 2024-04-02
• Primary completion: 2025-06-24
• Completion: 2025-06-24
• First posted: 2024-03-20
• Last updated: 2025-07-18

Locations

2 sites across 1 country: Switzerland