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

NCT05387525 | Active Not Recruiting Phase 4

• 2 other identifiers: M-14789-412021-004349-18
• Study Type: interventional
• Target: 447
• Locations: 6 countries
• Sites: 49

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF)

  Percentage of participants with histologically confirmed invasive SCC in the TF will be reported as assessed by dermoscopy.

  Up to 3 years

Secondary Outcomes (9)

• Number of Participants With Adverse Events (AEs)

  Up to 3 years

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 3 years

• Percentage of Participants With any Other Skin Cancer (Other Than SCC) in the TF

  Up to 3 years

• Time to Occurrence of Invasive SCC From Baseline in the TF

  Up to 3 years

• Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course

  Up to 3 years

Study Arms (2)

Tirbanibulin 10 milligram per gram (mg/g) ointment

EXPERIMENTAL

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.

Drug: Tirbanibulin (Klisyri®) 10 mg/g ointment

Diclofenac Sodium 3% Gel

ACTIVE COMPARATOR

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.

Drug: Diclofenac Sodium 3% Gel

Interventions

Tirbanibulin (Klisyri®) 10 mg/g ointment 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).

Also known as: Klisyri®

Tirbanibulin 10 milligram per gram (mg/g) ointment

Diclofenac Sodium 3% Gel DRUG

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

Diclofenac Sodium 3% Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (49)

Almirall Investigation Site 102

Lille, France

Location

Almirall Investigation Site 103

Marseille, France

Location

Almirall Investigation Site 104

Nice, France

Location

Almirall Investigational Site 106

Paris, France

Location

Almirall Investigational Site 105

Rouen, France

Location

Almirall Investigational Site 101

Saint-Priest-en-Jarez, France

Location

Almirall Investigational Site 205

Augsburg, Germany

Location

Almirall Investigational Site 211

Bad Bentheim, Germany

Location

Almirall Investigation Site 201

Bochum, Germany

Location

Almirall Investigational Site 214

Bochum, Germany

Location

Almirall Investigational Site 212

Bonn, Germany

Location

Almirall Investigational Site 208

Detmold, Germany

Location

Almirall Investigational Site 210

Dresden, Germany

Location

Almirall Investigational Site 204

Erlangen, Germany

Location

Almirall Investigational Site 206

Hamburg, Germany

Location

Almirall Investigational Site 213

Hamburg, Germany

Location

Almirall Investigational Site 207

Marburg, Germany

Location

Almirall Investigational Site 209

Merzig, Germany

Location

Almirall Investigation Site 202

Recklinghausen, Germany

Location

Almirall Investigational Site 309

Arezzo, Italy

Location

Almirall Investigational Site 302

Brescia, Italy

Location

Almirall Investigational Site 304

Genova, Italy

Location

Almirall Investigational Site 308

Modena, Italy

Location

Almirall Investigational Site 301

Napoli, Italy

Location

Almirall Investigational Site 303

Reggio Emilia, Italy

Location

Almirall Investigational Site 305

Roma, Italy

Location

Almirall Investigational Site 306

Roma, Italy

Location

Almirall Investigational Site 307

Roma, Italy

Location

Almirall Investigational Site 310

Rozzano, Italy

Location

Almirall Investigational Site 403

Lublin, Poland

Location

Almirall Investigational Site 406

Rzeszów, Poland

Location

Almirall Investigational Site 407

Warsaw, Poland

Location

Almirall Investigational Site 401

Wroclaw, Poland

Location

Almirall Investigational Site 402

Wroclaw, Poland

Location

Almirall Investigational Site 502

Barcelona, Spain

Location

Almirall Investigational Site 508

Barcelona, Spain

Location

Almirall Investigational Site 510

Barcelona, Spain

Location

Almirall Investigational Site 507

Granada, Spain

Location

Almirall Investigational Site 509

Granada, Spain

Location

Almirall Investigational Site 503

Madrid, Spain

Location

Almirall Investigational Site 504

Salamanca, Spain

Location

Almirall Investigational Site 505

Seville, Spain

Location

Almirall Investigational Site 506

Valencia, Spain

Location

Almirall Investigational Site 501

Zaragoza, Spain

Location

Almirall Investigational Site 703

London, United Kingdom

Location

Almirall Investigational Site 709

London, United Kingdom

Location

Almirall Investigational Site 708

Oxford, United Kingdom

Location

Almirall Investigational Site 704

Poole, United Kingdom

Location

Almirall Investigational Site 706

Weston-super-Mare, United Kingdom

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

tirbanibulin; Ointments; Diclofenac; Gels

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Colloids; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: October 24, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); FR (6); ES (10); IT (10); DE (13); PL (5)