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

NCT ID: NCT05387525

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2027-07-31

Brief 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.

Conditions

Keratosis, Actinic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tirbanibulin 10 milligram per gram (mg/g) ointment

Participants will apply tirbanibulin ointment 10 mg/g once daily to the treatment field (TF) for 5 consecutive days beginning Day 1. At subsequent visits, participants will have the option of an additional 5-day course(s) (with at least 16 weeks between starting date of treatment courses) at the discretion of the investigator if actinic keratosis (AK) lesions are present in the TF and physical treatment is not appropriate.

Group Type: EXPERIMENTAL

Tirbanibulin (Klisyri®) 10 mg/g ointment

Intervention Type: DRUG

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 sodium 3% gel twice daily to the TF for 60 to 90 days beginning Day 1, with the option of further courses every 6 months (with at least 6 months between starting date of treatment courses) if lesions are found to be present in the TF at follow up visits and physical treatment is not appropriate.

Group Type: ACTIVE_COMPARATOR

Diclofenac Sodium 3% Gel

Intervention Type: DRUG

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

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).

Intervention Type: DRUG

Diclofenac Sodium 3% Gel

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

Intervention Type: DRUG

Other Intervention Names

Klisyri®

Eligibility Criteria

Inclusion Criteria

• A treatment field (TF) on the face or scalp (excluding lips, eyelids, ears, and inside the nostrils), that: a) is a contiguous area measuring 25 cm^2, b) contains 2 to 8 clinically typical, visible, and discrete actinic keratosis (AK) lesions, and c) has an overall clinical picture that is consistent with Olsen grade 1
• If a women of child-bearing potential (WOCBP), that is, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 3 months prior to Screening), she must: a) Have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration. b) Be using effective methods of birth control. c) Agree to have pregnancy tests while in the study and at the end of the study
• Participants should be willing to avoid sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study
• Participants should have the ability to understand the purpose and risks of the study, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines

Exclusion Criteria

• The location of the TF is: a) on any location other than the face or scalp. b) within 5 centimeters (cm) of an incompletely healed wound. c) Within 10 cm of a suspected basal cell carcinoma (BCC) or other neoplasm. d) on the lips, eyelids, ears, or inside the nostrils, periorbital, perioral, or the skin surrounding the nostrils
• Presence in the TF of: a) clinically atypical and/or rapidly changing AK lesions b) hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions), and/or cutaneous horn. c) confluent AK lesions (that is, non-discrete lesions, as per inclusion criterion 2). d) Persisting AK lesions at the screening visit following topical treatment with diclofenac sodium 3 percent (%) gel
• History of any malignant skin tumour in the TF or history of skin tumour in any region of the body which has metastasized or in which metastasis within the study period is likely
• History of any malignant tumour with systemic antitumor treatment (including radiotherapy) within 12 weeks prior to the Screening Visit or systemic antitumor treatment is expected while on the study
• Immunocompromised participants, including participants with a history of chronic systemic lymphoma or chronic myeloid leukaemia, or organ transplant recipients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Napoli, , 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

Countries

France; Germany; Italy; Poland; Spain; United Kingdom

Other Identifiers

2021-004349-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M-14789-41

Identifier Type: -

Identifier Source: org_study_id