A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses

NCT05741294 | Completed Phase 4 Results

• 2 other identifiers: M-14789-422022-001251-16
• Study Type: interventional
• Target: 334
• Locations: 2 countries
• Sites: 37

Brief Summary

The purpose of the study is to assess treatment satisfaction on Day 57 in participants with Actinic Keratoses (AK) of the face or scalp following treatment with tirbanibulin ointment 1 percent (%) administered once daily for 5 consecutive days.

Conditions

Actinic Keratosis

Keywords

Keratosis; Tirbanibulin

Outcome Measures

Primary Outcomes (1)

• Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57

  TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.

  At Day 57

Secondary Outcomes (11)

• Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57

  Baseline, Day 57

• Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8

  At Day 8

• Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57

  At Day 57

• Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57

  At Day 57

• Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57

  At Day 57

Study Arms (1)

Tirbanibulin 2.5 milligrams (mg) ointment

EXPERIMENTAL

Participants will apply tirbanibulin ointment- topically at a dose of 2.5 mg once daily for 5 consecutive days- on the face or scalp.

Drug: Tirbanibulin 2.5 mg ointment

Interventions

Tirbanibulin 2.5 mg ointment DRUG

Participants will apply tirbanibulin 2.5 mg ointment topically for 5 consecutive days over 25 square centimeters (cm\^2) of the face or scalp.

Tirbanibulin 2.5 milligrams (mg) ointment

Eligibility Criteria

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

You may qualify if:

• Written informed consent.
• Males or females aged greater than or equal to (\>=)18 years.
• Diagnosis of clinically typical AK in one contiguous area on the face or scalp with a treatment area of 25\^cm2 containing 4-8 AK lesions.
• Participants not previously treated for AK on the current treatment area of the face or scalp in the last 6 months. However, previous AK treatment in other small areas (up to 25\^cm2) in the last greater than \>1 to less than \<6 months is allowed.
• Females must be postmenopausal (A female said to be postmenopausal should be \>45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of child-bearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive intercourse.
• Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment.
• All participants must agree not to donate sperm or eggs from screening through 90 days following their last dose of study treatment.
• Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0 prior to dose administration.
• Willing to avoid excessive sun or UV (ultraviolet light) light exposure to the face or scalp.

You may not qualify if:

• Clinically atypical and/or rapidly changing AK lesions.
• Location of the treatment area is within 5 cm of an incompletely healed wound or a suspected basal cell carcinoma (BCC)/squamous cell carcinoma (SCC).
• Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., open wounds, scarring) in the treatment area that might interfere with the study results or suppose an unacceptable risk.
• History of sensitivity to any of the ingredients in the tirbanibulin formulation.
• Participated in a clinical trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
• Participants with a history of tirbanibulin treatment for AK lesions and participants who are currently on tirbanibulin treatment for AK lesions.
• Use of immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/ interferon inducers and systemic immunosuppressive agents (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 4 weeks prior to the Screening visit, except for organ transplant recipients under stable immunosuppressive therapy for 6 months.
• Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit.
• Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit:
• Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area
• Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area
• Topical salves (nonmedicated/nonirritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area.
• Females who are pregnant or nursing.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (37)

Almirall Investigational Site 1

Cagliari, Italy

Location

Almirall Investigational Site 2

Catania, Italy

Location

Almirall Investigational Site 3

Napoli, Italy

Location

Almirall Investigational Site 4

Pisa, Italy

Location

Almirall Investigational Site 5

Rimini, Italy

Location

Almirall Investigational Site 6

Torino, Italy

Location

Almirall Investigational Site 7

Trieste, Italy

Location

Almirall Investigational Site 1

Alcorcón, Spain

Location

Almirall Investigational Site 2

Alicante, Spain

Location

Almirall Investigational Site 3

Badalona, Spain

Location

Almirall Investigational Site 4

Barcelona, Spain

Location

Almirall Investigational Site 5

Barcelona, Spain

Location

Almirall Investigational Site 6

Barcelona, Spain

Location

Almirall Investigational Site 7

Barcelona, Spain

Location

Almirall Investigational Site 8

Bilbao, Spain

Location

Almirall Investigational Site 9

Córdoba, Spain

Location

Almirall Investigational Site 10

Fuenlabrada, Spain

Location

Almirall Investigational Site 11

Granada, Spain

Location

Almirall Investigational Site 12

Madrid, Spain

Location

Almirall Investigational Site 13

Madrid, Spain

Location

Almirall Investigational Site 14

Madrid, Spain

Location

Almirall Investigational Site 15

Madrid, Spain

Location

Almirall Investigational Site 16

Majadahonda, Spain

Location

Almirall Investigational Site 17

Málaga, Spain

Location

Almirall Investigational Site 18

Palma, Spain

Location

Almirall Investigational Site 19

Pontevedra, Spain

Location

Almirall Investigational Site 20

Sabadell, Spain

Location

Almirall Investigational Site 21

Salamanca, Spain

Location

Almirall Investigational Site 22

Santa Cruz de Tenerife, Spain

Location

Almirall Investigational Site 23

Seville, Spain

Location

Almirall Investigational Site 24

Seville, Spain

Location

Almirall Investigational Site 25

Valencia, Spain

Location

Almirall Investigational Site 26

Valencia, Spain

Location

Almirall Investigational Site 27

Valencia, Spain

Location

Almirall Investigational Site 28

Vigo, Spain

Location

Almirall Investigational Site 29

Zaragoza, Spain

Location

Almirall Investigational Site 30

Zaragoza, Spain

Location

MeSH Terms

Conditions

Keratosis, Actinic; Keratosis

Interventions

tirbanibulin; Ointments

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Valentina Cappello/Global Medical Operations Manager
• Organization: Almirall S.A

valentina.cappello@almirall.com

+34932913000

Study Officials

• Alberto Lecchi

  Almirall, srl

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: January 20, 2023
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: February 20, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (30); IT (7)