Clinical trial NCT05741294: A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses
Official title: Open Phase IV Study to Assess the Impact of Tirbanibulin on the Wellbeing of Patients With Actinic Keratoses (TIRBASKIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis
Keywords: Keratosis
Tirbanibulin
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent.
2. Males or females aged greater than or equal to (\>=)18 years.
3. 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.
4. 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.
5. 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.
6. 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.
7. All participants must agree not to donate sperm or eggs from screening through 90 days following their last dose of study treatment.
8. 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.
9. Willing to avoid excessive sun or UV (ultraviolet light) light exposure to the face or scalp.

Exclusion Criteria:

1. Clinically atypical and/or rapidly changing AK lesions.
2. 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).
3. 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.
4. History of sensitivity to any of the ingredients in the tirbanibulin formulation.
5. 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.
6. Participants with a history of tirbanibulin treatment for AK lesions and participants who are currently on tirbanibulin treatment for AK lesions.
7. 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.
8. Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit.
9. 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.
10. Females who are pregnant or nursing.

Primary outcomes:
measure: Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57
timeFrame: At Day 57
Secondary outcomes:
measure: Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57
timeFrame: Baseline, Day 57
measure: Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8
timeFrame: At Day 8
measure: Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57
timeFrame: At Day 57
measure: Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57
timeFrame: At Day 57
measure: Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57
timeFrame: At Day 57
measure: Percentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57
timeFrame: At Day 57
measure: Percentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57
timeFrame: At Day 57
measure: Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57
timeFrame: At Day 57
measure: Percentage of Participants by Olsen Characterization at Baseline and Day 57
timeFrame: Baseline (Day 0) and Day 57
measure: Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint
timeFrame: Baseline, Day 8, Day 15, Day 29, and Day 57
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs
timeFrame: From start of study administration up to Day 57
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Almirall Investigational Site 1
city: Catania
country: Italy
facility: Almirall Investigational Site 2
city: Napoli
country: Italy
facility: Almirall Investigational Site 3
city: Pisa
country: Italy
facility: Almirall Investigational Site 4
city: Rimini
country: Italy
facility: Almirall Investigational Site 5
city: Torino
country: Italy
facility: Almirall Investigational Site 6
city: Trieste
country: Italy
facility: Almirall Investigational Site 7
city: Alcorcón
country: Spain
facility: Almirall Investigational Site 1
city: Alicante
country: Spain
facility: Almirall Investigational Site 2
city: Badalona
country: Spain
facility: Almirall Investigational Site 3
city: Barcelona
country: Spain
facility: Almirall Investigational Site 4
city: Barcelona
country: Spain
facility: Almirall Investigational Site 5
city: Barcelona
country: Spain
facility: Almirall Investigational Site 6
city: Barcelona
country: Spain
facility: Almirall Investigational Site 7
city: Bilbao
country: Spain
facility: Almirall Investigational Site 8
city: Córdoba
country: Spain
facility: Almirall Investigational Site 9
city: Fuenlabrada
country: Spain
facility: Almirall Investigational Site 10
city: Granada
country: Spain
facility: Almirall Investigational Site 11
city: Madrid
country: Spain
facility: Almirall Investigational Site 12
city: Madrid
country: Spain
facility: Almirall Investigational Site 13
city: Madrid
country: Spain
facility: Almirall Investigational Site 14
city: Madrid
country: Spain
facility: Almirall Investigational Site 15
city: Majadahonda
country: Spain
facility: Almirall Investigational Site 16
city: Málaga
country: Spain
facility: Almirall Investigational Site 17
city: Palma
country: Spain
facility: Almirall Investigational Site 18
city: Pontevedra
country: Spain
facility: Almirall Investigational Site 19
city: Sabadell
country: Spain
facility: Almirall Investigational Site 20
city: Salamanca
country: Spain
facility: Almirall Investigational Site 21
city: Santa Cruz de Tenerife
country: Spain
facility: Almirall Investigational Site 22
city: Sevilla
country: Spain
facility: Almirall Investigational Site 23
city: Sevilla
country: Spain
facility: Almirall Investigational Site 24
city: Valencia
country: Spain
facility: Almirall Investigational Site 25
city: Valencia
country: Spain
facility: Almirall Investigational Site 26
city: Valencia
country: Spain
facility: Almirall Investigational Site 27
city: Vigo
country: Spain
facility: Almirall Investigational Site 28
city: Zaragoza
country: Spain
facility: Almirall Investigational Site 29
city: Zaragoza
country: Spain
facility: Almirall Investigational Site 30
Study officials:
affiliation: Almirall, srl
name: Alberto Lecchi
role: STUDY_DIRECTOR
References: