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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.
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
Conditions
Interventions
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).
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