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ACTIVE NOT RECRUITING
NCT05387525
PHASE4

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

Sponsor: Almirall, S.A.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.

Official title: A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients With Actinic Keratosis on the Face or Scalp

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

447

Start Date

2022-10-24

Completion Date

2027-07

Last Updated

2025-02-11

Healthy Volunteers

No

Interventions

DRUG

Tirbanibulin (Klisyri®) 10 mg/g ointment

Participants will apply tirbanibulin 10 mg/g ointment topically for 5 days over 25 cm\^2 of the face or scalp with Actinic Keratosis (AK).

DRUG

Diclofenac Sodium 3% Gel

Participants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days.

Locations (49)

Almirall Investigation Site 102

Lille, France

Almirall Investigation Site 103

Marseille, France

Almirall Investigation Site 104

Nice, France

Almirall Investigational Site 106

Paris, France

Almirall Investigational Site 105

Rouen, France

Almirall Investigational Site 101

Saint-Priest-en-Jarez, France

Almirall Investigational Site 205

Augsburg, Germany

Almirall Investigational Site 211

Bad Bentheim, Germany

Almirall Investigation Site 201

Bochum, Germany

Almirall Investigational Site 214

Bochum, Germany

Almirall Investigational Site 212

Bonn, Germany

Almirall Investigational Site 208

Detmold, Germany

Almirall Investigational Site 210

Dresden, Germany

Almirall Investigational Site 204

Erlangen, Germany

Almirall Investigational Site 206

Hamburg, Germany

Almirall Investigational Site 213

Hamburg, Germany

Almirall Investigational Site 207

Marburg, Germany

Almirall Investigational Site 209

Merzig, Germany

Almirall Investigation Site 202

Recklinghausen, Germany

Almirall Investigational Site 309

Arezzo, Italy

Almirall Investigational Site 302

Brescia, Italy

Almirall Investigational Site 304

Genova, Italy

Almirall Investigational Site 308

Modena, Italy

Almirall Investigational Site 301

Naples, Italy

Almirall Investigational Site 303

Reggio Emilia, Italy

Almirall Investigational Site 305

Roma, Italy

Almirall Investigational Site 306

Roma, Italy

Almirall Investigational Site 307

Roma, Italy

Almirall Investigational Site 310

Rozzano, Italy

Almirall Investigational Site 403

Lublin, Poland

Almirall Investigational Site 406

Rzeszów, Poland

Almirall Investigational Site 407

Warsaw, Poland

Almirall Investigational Site 401

Wroclaw, Poland

Almirall Investigational Site 402

Wroclaw, Poland

Almirall Investigational Site 502

Barcelona, Spain

Almirall Investigational Site 508

Barcelona, Spain

Almirall Investigational Site 510

Barcelona, Spain

Almirall Investigational Site 507

Granada, Spain

Almirall Investigational Site 509

Granada, Spain

Almirall Investigational Site 503

Madrid, Spain

Almirall Investigational Site 504

Salamanca, Spain

Almirall Investigational Site 505

Seville, Spain

Almirall Investigational Site 506

Valencia, Spain

Almirall Investigational Site 501

Zaragoza, Spain

Almirall Investigational Site 703

London, United Kingdom

Almirall Investigational Site 709

London, United Kingdom

Almirall Investigational Site 708

Oxford, United Kingdom

Almirall Investigational Site 704

Poole, United Kingdom

Almirall Investigational Site 706

Weston-super-Mare, United Kingdom