Patient- and Clinician-reported Outcomes, Safety and Efficacy Profile of Tirbanibulin 1% for Actinic Keratosis Under Conditions Close to Routine Clinical Practice in Spain and Italy (TIRBASKIN Study)
Gilaberte, Y. (Universidad de Zaragoza) ; Yélamos, O. ; Cañueto, J. ; Serra-Guillén, C. ; Conti, A. ; Pajuelo, F. ; Lecchi, A. ; Cappello, V. ; Kostov, B. ; Padullés, L. ; Romanelli, M.
Resumen: Objective
To assess patient- and clinician-reported outcomes, efficacy, and safety of tirbanibulin 1% administered to patients with actinic keratoses (AKs) in Spain and Italy.
Methods
TIRBASKIN is a multicenter, single-cohort, phase IV, low-interventional clinical study conducted among adults with 4–8 AK lesions on the face or scalp in an area ≤25 cm2. Patients applied tirbanibulin for 5 consecutive days. The primary endpoint was treatment satisfaction on day 57 (D57), assessed with the Treatment Satisfaction Questionnaire for Medication 9 (TSQM-9). Efficacy was assessed by the percentage of patients with complete clearance (CC) and partial clearance (PC) at D57. Tolerability was assessed by local tolerability signs (LTSs), also known as local skin reactions.
Results
A total of 328 patients (mean age, 74.8 years; male, 83.5%; Fitzpatrick skin type II, 53.7%; AKs on the scalp, 52.7%) completed study assessments at D57. Patients reported high levels of satisfaction with tirbanibulin as assessed by TSQM-9 (effectiveness mean score, 73.6; convenience mean score, 82.8; global satisfaction mean score, 76.9). Moreover, 87.7% of clinicians and 81.8% of patients reported overall satisfaction with tirbanibulin as much/somewhat better compared with previous topical treatment. In addition, 87.1% of clinicians and 86.3% of patients reported a likelihood of reconsidering tirbanibulin in the future, if needed. CC was achieved by 54.3% of patients and PC by 76.2%. At D8, the most frequent LTSs were erythema/redness (mild/moderate, 72.2%; severe, 2.2%) and flaking/scaling (mild/moderate, 34.6%; severe, 0.6%), which had mostly resolved by D57.
Conclusions
Patients’ and clinicians’ satisfaction was high, and both groups reported a high likelihood of using tirbanibulin again, if needed.
Idioma: Inglés
DOI: 10.1016/j.ad.2026.104632
Año: 2026
Publicado en: Actas Dermo-Sifiliograficas 117, 7 (2026), 104632 [8 pp.]
ISSN: 0001-7310
Tipo y forma: Article (Published version)
Área (Departamento): Área Dermatología (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. If you remix, transform, or build upon the material, you may not distribute the modified material.
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To assess patient- and clinician-reported outcomes, efficacy, and safety of tirbanibulin 1% administered to patients with actinic keratoses (AKs) in Spain and Italy.
Methods
TIRBASKIN is a multicenter, single-cohort, phase IV, low-interventional clinical study conducted among adults with 4–8 AK lesions on the face or scalp in an area ≤25 cm2. Patients applied tirbanibulin for 5 consecutive days. The primary endpoint was treatment satisfaction on day 57 (D57), assessed with the Treatment Satisfaction Questionnaire for Medication 9 (TSQM-9). Efficacy was assessed by the percentage of patients with complete clearance (CC) and partial clearance (PC) at D57. Tolerability was assessed by local tolerability signs (LTSs), also known as local skin reactions.
Results
A total of 328 patients (mean age, 74.8 years; male, 83.5%; Fitzpatrick skin type II, 53.7%; AKs on the scalp, 52.7%) completed study assessments at D57. Patients reported high levels of satisfaction with tirbanibulin as assessed by TSQM-9 (effectiveness mean score, 73.6; convenience mean score, 82.8; global satisfaction mean score, 76.9). Moreover, 87.7% of clinicians and 81.8% of patients reported overall satisfaction with tirbanibulin as much/somewhat better compared with previous topical treatment. In addition, 87.1% of clinicians and 86.3% of patients reported a likelihood of reconsidering tirbanibulin in the future, if needed. CC was achieved by 54.3% of patients and PC by 76.2%. At D8, the most frequent LTSs were erythema/redness (mild/moderate, 72.2%; severe, 2.2%) and flaking/scaling (mild/moderate, 34.6%; severe, 0.6%), which had mostly resolved by D57.
Conclusions
Patients’ and clinicians’ satisfaction was high, and both groups reported a high likelihood of using tirbanibulin again, if needed.
Idioma: Inglés
DOI: 10.1016/j.ad.2026.104632
Año: 2026
Publicado en: Actas Dermo-Sifiliograficas 117, 7 (2026), 104632 [8 pp.]
ISSN: 0001-7310
Tipo y forma: Article (Published version)
Área (Departamento): Área Dermatología (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. If you remix, transform, or build upon the material, you may not distribute the modified material. Exportado de SIDERAL (2026-04-30-13:58:02)
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Record created 2026-04-30, last modified 2026-04-30