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    Summary
    EudraCT Number:2022-001251-16
    Sponsor's Protocol Code Number:M-14789-42
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-10-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-001251-16
    A.3Full title of the trial
    Open phase IV study to assess the impact of tirbanibulin on the well-being of patients with actinic keratoses (TIRBASKIN).
    Studio in aperto di fase IV per valutare l'impatto di tirbanibulina sul benessere dei pazienti affetti da cheratosi attinica (TIRBASKIN).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open phase IV study to assess the impact of tirbanibulin on the well-being
    of patients with actinic keratoses (TIRBASKIN).
    Studio in aperto di fase IV per valutare l'impatto di tirbanibulina sul benessere dei pazienti affetti da cheratosi attinica (TIRBASKIN).
    A.3.2Name or abbreviated title of the trial where available
    Impact of tirbanibulin on the well-being of patients with actinic keratoses.
    Impatto di tirbanibulina sul benessere dei pazienti affetti da cheratosi attinica.
    A.4.1Sponsor's protocol code numberM-14789-42
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlmirall SA
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlmirall S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPIS s.r.l.
    B.5.2Functional name of contact pointDipartimento Medico
    B.5.3 Address:
    B.5.3.1Street AddressPalazzo Aliprandi, Via Matteotti 10
    B.5.3.2Town/ cityDesio
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number003903626331
    B.5.5Fax number00390362633633
    B.5.6E-mailinfo.studiclinici@opisresearch.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Klisyri
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall S.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTirbanibulin
    D.3.2Product code [M-14789-42]
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTirbanibulin
    D.3.9.2Current sponsor codeM-14789-42
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Actinic keratosis (AK) of the face and scalp
    Cheratosi attinica (AK) del viso e del cuoio capelluto
    E.1.1.1Medical condition in easily understood language
    Actinic keratosis (AK) of the face and scalp
    Cheratosi attinica (AK) del viso e del cuoio capelluto
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    L’obiettivo primario è valutare la soddisfazione per il trattamento al Giorno 57 in pazienti con AK al viso o al cuoio capelluto dopo il trattamento con tirbanibulina unguento all'1% somministrato una volta al giorno per 5 giorni consecutivi.
    E.2.2Secondary objectives of the trial
    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.
    L’obiettivo secondario è valutare gli esiti riferiti dal paziente, quelli riferiti dal medico, l’efficacia e la sicurezza dopo il trattamento con tirbanibulina unguento all’1% somministrato una volta al giorno per 5 giorni consecutivi.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 <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 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.
    1. Consenso informato scritto.
    2. Uomini o donne di età =18 anni.
    3. Diagnosi di AK clinicamente tipica in un'area contigua del viso o del cuoio capelluto con un'area di trattamento di 25 cm2 che presenta 4-8 lesioni AK.
    4. Pazienti non trattati in precedenza per AK sull'attuale area di trattamento del viso o del cuoio capelluto negli ultimi 6 mesi. È tuttavia consentito un precedente trattamento AK in altre piccole aree (fino a 25 cm2) in un periodo compreso tra > 1 e < 6 mesi precedenti.
    5. Le donne devono essere in postmenopausa (una donna in postmenopausa deve avere un'età > 45 anni con almeno 12 mesi di amenorrea), devono essere chirurgicamente sterili (a seguito di isterectomia, ovariectomia bilaterale o legatura delle tube); oppure, se in età fertile, devono utilizzare un metodo contraccettivo altamente efficace per almeno 30 giorni o per 1 ciclo mestruale, a seconda di quale dei due sia più lungo, prima del trattamento in studio e devono acconsentire a continuare a usare un metodo contraccettivo altamente efficace per almeno 30 giorni dopo l'ultima dose del trattamento in studio. La contraccezione altamente efficace comprende i contraccettivi ormonali orali, l'impianto contraccettivo ormonale, l'iniezione o il cerotto, il dispositivo intrauterino o la completa astinenza dai rapporti sessuali.
    6. I maschi sessualmente attivi e non vasectomizzati, la cui partner sia in grado di riprodursi, devono acconsentire a utilizzare una contraccezione di barriera dal momento dello screening fino a 90 giorni dopo l'ultima dose del trattamento in studio.
    7. Tutti i partecipanti devono aver acconsentito a non donare sperma o ovuli dal momento dello screening fino a 90 giorni dopo l'ultima dose del trattamento in studio.
    8. Le donne in età fertile devono avere un test di gravidanza su siero negativo allo screening e un test di gravidanza sulle urine negativo il Giorno 0 prima della somministrazione della dose.
    9. I partecipanti devono dichiararsi disposti a non esporsi eccessivamente alla luce del sole o ai raggi UV sul viso o sul cuoio capelluto.
    E.4Principal 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
    1. Lesioni AK clinicamente atipiche e/o in rapido cambiamento.
    2. L'area di trattamento si trova entro 5 cm da una ferita non completamente cicatrizzata o da un sospetto carcinoma a cellule basali (BCC)/carcinoma a cellule squamose (SCC).
    3. Malattie della pelle (ad es. dermatite atopica, psoriasi, eczema) o condizioni (ad es. ferite aperte, cicatrici) nell'area di trattamento, che potrebbero interferire con i risultati dello studio o comportare un rischio inaccettabile.
    4. Storia di sensibilità a uno qualsiasi degli ingredienti nella formulazione di tirbanibulina.
    5. Il soggetto ha partecipato a una sperimentazione clinica durante la quale è stato somministrato un farmaco sperimentale in studio entro un intervallo di 30 giorni o 5 emivite (a seconda di quale dei due sia superiore), prima della somministrazione.
    6. Pazienti precedentemente trattati con tirbanibulina per lesioni AK e pazienti attualmente in trattamento con tirbanibulina per lesioni AK.
    7. Uso di immunomodulatori (ad es. azatioprina), farmaci citotossici (ad es. ciclofosfamide, vinblastina, clorambucile, metotrexato) o interferoni/induttori di interferoni e immunosoppressori sistemici (ad es. ciclosporina, prednisone, metotrexato, alefacept, infliximab) entro 4 settimane prima della visita di screening, ad eccezione dei riceventi di trapianto d'organo in terapia immunosoppressiva stabile da 6 mesi.
    8. Uso di retinoidi sistemici (ad es. isotretinoina, acitretina, bexarotene) nei 6 mesi precedenti la visita di screening.
    9. Uso delle seguenti terapie e/o medicinali nelle 2 settimane precedenti la visita di screening:
    • Procedure cosmetiche o terapeutiche (ad esempio, uso di azoto liquido, escissione chirurgica, curettage, dermoabrasione, peeling chimico di media o maggiore profondità, laser resurfacing) nell'area di trattamento o entro 2 cm dall’area di trattamento selezionata
    • Prodotti terapeutici contenenti acidi (ad esempio, acido salicilico o acidi della frutta, come gli acidi alfa e beta-idrossilici e l'acido glicolico), retinoidi topici o peeling chimici leggeri nell'area di trattamento o entro 2 cm dall'area di trattamento selezionata
    • Pomate topiche (sono accettabili lozioni e creme non medicate/non irritanti) o steroidi topici nell'area di trattamento o entro 2 cm dall'area di trattamento selezionata; abbronzanti artificiali nell'area di trattamento o entro 5 cm dall'area di trattamento selezionata
    10. Donne in gravidanza o in allattamento
    E.5 End points
    E.5.1Primary end point(s)
    The primary trial endpoint is Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) score
    L'endpoint primario dello studio è il punteggio del Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9 - Questionario di soddisfazione per il trattamento farmacologico, versione 9)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 57
    Al giorno 57
    E.5.2Secondary 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)
    Esiti riferiti dal paziente:
    • Variazione rispetto al basale dello Skindex-16
    • Proprietà organolettiche di tirbanibulina valutate su una scala Likert
    • TSQM versione 1.4 (TSQM 1.4)
    • Preferenza terapeutica del paziente valutata tramite domande da 1 (D1) a 9 (D9) dell'Expert Panel Questionnaire (EPQ - Questionario del gruppo di esperti) al
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient-Reported Outcomes:
    • at day 57
    • at day 8
    • at day 57
    • at day 57
    Esiti riferiti dal paziente:
    • al giorno 57
    • al giorno 8
    • al giorno 57
    • al giorno 57
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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.
    Valutare la soddisfazione per il trattamento al Giorno 57 in pazienti con AK al viso o al cuoio capelluto dopo il trattamento con tirbanibulina unguento all'1% somministrato una volta al giorno per 5 giorni consecutivi.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    F.4.2.2In the whole clinical trial 420
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-22
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