Actinic keratosis (AK) of the face and scalp MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Klisyri
Product Name: Tirbanibulin
Product Code: [M-14789-42]
Pharmaceutical Form: Ointment
INN or Proposed INN: Tirbanibulin
Current Sponsor code: M-14789-42
Concentration unit: mg/g mill
Sponsors
Almirall SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Males or females aged =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. Patients 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 25cm2) in the last >1 to 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 implant, injection or patch, intrauterine device, or complete abstinence from sexual 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 subjects 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 light exposure to the face or scalp. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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. Patients with a history of tirbanibulin treatment for AK lesions and patients 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess treatment satisfaction on Day 57 in patients with AK of the face or scalp following treatment with tirbanibulin ointment 1% administered once daily for 5 consecutive days.;Secondary Objective: The secondary objective is to evaluate patient-reported outcomes, physician-reported outcomes, efficacy, and safety following treatment with tirbanibulin ointment 1% administered once daily for 5 consecutive days.;Primary end point(s): The primary trial endpoint is Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) score;Timepoint(s) of evaluation of this end point: At day 57 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Patient-Reported Outcomes: • Change from baseline in Skindex-16 • Organoleptic properties of tirbanibulin assessed on a Likert Scale • TSQM Version 1.4 (TSQM 1.4) • Patient treatment preference assessed through question 1 (Q1) to question 9 (Q9) of the Expert Panel Questionnaire (EPQ);Timepoint(s) of evaluation of this end point: Patient-Reported Outcomes: • at day 57 • at day 8 • at day 57 • at day 57 | — |
Countries
Italy, Spain
Contacts
Public ContactDipartimento Medico
OPIS s.r.l.
Outcome results
None listed