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COMPLETED
NCT06135415
PHASE3

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

Sponsor: Almirall, S.A.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 square centimeters (cm\^2) and up to 100 cm\^2 in adult participants with actinic keratosis (AK).

Official title: A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm^2 and up to 100 cm^2 in Adult Patients With Actinic Keratosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2023-12-21

Completion Date

2025-11-25

Last Updated

2026-06-30

Healthy Volunteers

No

Interventions

DRUG

Tirbanibulin

Participants will apply tirbanibulin ointment topically on the face or balding scalp with AK.

OTHER

Vehicle ointment

Participants will apply vehicle ointment topically on the face or balding scalp with AK.

Locations (35)

Site 17

Augsburg, Germany

Site 1

Bad Bentheim, Germany

Site 3

Bochum, Germany

Site 18

Dresden, Germany

Site 2

Hamburg, Germany

Site 5

Hamburg, Germany

Site 4

Mahlow, Germany

Site 6

Wuppertal, Germany

Site 24

Bari, Italy

Site 25

Bologna, Italy

Site 19

Brescia, Italy

Site 26

Cagliari, Italy

Site 23

Florence, Italy

Site 22

Pisa, Italy

Site 27

Reggio Emilia, Italy

Site 20

Roma, Italy

Site 21

Roma, Italy

Site 7

Roma, Italy

Site 29

Heemstede, Netherlands

Site 28

Maastricht, Netherlands

Site 31

Krakow, Poland

Site 30

Ossy, Poland

Site 10

Warsaw, Poland

Site 11

Warsaw, Poland

Site 9

Warsaw, Poland

Site 8

Wroclaw, Poland

Site 12

Barcelona, Spain

Site 14

Barcelona, Spain

Site 34

Barcelona, Spain

Site 33

Granada, Spain

Site 13

Madrid, Spain

Site 32

Salamanca, Spain

Site 15

Valencia, Spain

Site 35

Valencia, Spain

Site 16

Zaragoza, Spain