NCT05279131

A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

A Phase 3, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% Applied to a Field of Approximately 100 cm2 on the Face or Balding Scalp in Adult Patients With Actinic Keratosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety, tolerability and treatment effect of tirbanibulin ointment 1% when applied to a field of approximately 100 cm\^2 on the face or balding scalp.

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
DRUG	Tirbanibulin ointment 1%	Applied topically for 5 days over a field of approximately 100 cm\^2 on the face or balding scalp with AK.

Timeline

• Start date: 2022-06-28
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2022-03-15
• Last updated: 2024-01-23
• Results posted: 2024-01-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study