1% Tirbanibulin Ointment for Actinic Keratoses on Upper Extremities - A Retrospective Case Review Study

Q: Who was included in the study of 1% tirbanibulin for actinic keratoses on the upper extremities?

Adults aged 18 or above with clinically typical non-hyperkeratotic AK lesions (Olsen grade I–II) on the upper extremities were included. Pregnant patients, those with known sensitivity to tirbanibulin or vehicle components, and those receiving other therapy in the prior 3 months were excluded.

Q: What treatment regimen and how was efficacy measured?

Patients applied 1% tirbanibulin ointment once daily for 5 consecutive days, covering up to a 25 cm2 area. Efficacy was assessed by complete clearance at 60 days (no AKs in the treatment area) and by partial clearance defined as a ≥75% reduction in lesion count.

Q: What were the main safety findings and how severe were local skin reactions?

Local skin reactions were recorded in 8 patients (36%) and were mostly categorized as mild (7 of 8, 88%). Reactions included erythema, scaling, swelling, crusting, vesiculation, and erosions, graded on a 4-point severity scale.

Sep 24, 2026

Uploaded by Elsa

Retrospective case review evidence assessed the real-world efficacy and safety of 1% tirbanibulin ointment for actinic keratoses on upper extremities. Adults with clinically typical non-hyperkeratotic AK lesions (Olsen grade I–II) were treated under daily-practice conditions with once-daily application for 5 consecutive days. Complete clearance at 60 days reached 45% (10 of 22 patients/cycles), with partial clearance (≥75%) in 82%. Local skin reactions occurred in 36% and were mostly mild, while adherence remained complete.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages3

Reading Time8 min

AccessFree to download

Materials and Methods

Participants and inclusion/exclusion criteria

Treatment regimen and outcomes

Results

Patient characteristics

Efficacy outcomes

Safety and local skin reactions

1/3 SHORT COMMUNICATION 1% Tirbanibulin Ointment for Actinic Keratoses on Upper Extremities: A Retrospective Case Review Study Álvaro IGLESIAS-PUZAS, Alberto CONDE-TABOADA, Lucía CAMPOS-MUÑOZ, Ana SIRGADO-MARTÍNEZ and Eduardo LÓPEZ-BRAN Dermatology Department, Hospital Universitario Clínico San Carlos, c/ Profesor Martín Lagos, s/n, ES-28040 Madrid, Spain. E-mail: [alvaroigpu@gmail.com](alvaroigpu@gmail.com) Accepted Sep 8, 2023; Published Oct 24, 2023 Acta Derm Venereol 2023; 103: adv15296 . DOI: 10.2340/actadv.v103.15296 The anatomical distribution of actinic keratoses (AKs) is the result of chronic and prolonged sun exposure, with more than 80% of cases located in the head, neck and upper extremities (1) . However, since most drug studies have been performed on the face and scalp, data on treatment of AK in other frequently affected areas, such as the upper extremities, maybe under-represented (2) . 1% Tirbanibulin ointment has been developed as a first-in-class anti-proliferative and pro-apoptotic agent for the treatment of AKs and has been approved by the European Medicines Agency and the U.S. Food and Drug Administration for usage on face and scalp area (3) . Its mechanism of action promotes the eradication of lesions through the inhibition of tubulin polymerization and Src signalling, among others (4). The aim of the current study is to examine the efficacy and safety of 1% tirbanibulin ointment for treating AKs in the upper extremities under daily practice conditions. MATERIALS AND METHODS This retrospective case review study was conducted between March and June 2023 at a single centre in Madrid, Spain. Subjects aged 18 years or above with clinically typical non-hyperkeratotic AK lesions (grade I–II according to Olsen’s classification) on their upper extremities were included. Patients were excluded if they were pregnant, had a known history of sensitivity to tirbanibulinor vehicle components, or had received another therapy within the study area during the previous 3 months. In all cases, dosage Table I. Patients’ demographic data at baseline | Variable | | | --- | --- | | Age, years, mean ±SD)
Sex, n (%) Male
Female Phototype, n (%)
III III
Personal history of skin cancer, n (%)
Basal cell carcinoma Squamous cell carcinoma Melanoma
Previous treatments for the same location, n (%)
Cryotherapy Diclofenac Imiquimod
Ingenol mebutate Photodynamic therapy 5-fluorouracil/10% salicylic acid | 73.9± 10.5
7 (41)
10 (59)
4 (24)
10 (59)
3 (17)
8 (47)
6 (35)
1 (6)
12 (70)
3 (18)
4 (24)
2 (12)
6 (35)
4 (24) | SD: standard deviation. followed indications from the summary of product characteristics (once daily, 5 consecutive days, covering up to a 25 cm2 area) . A clinical assessment of target lesions was performed at screening and at 60 days after treatment. The primary outcome was a complete clearance rate, defined as the proportion of subjects with no AKs in the treatment area. Secondary assessments included percentage change of the number of lesions from baseline, partial clearance rate (defined as 75% reduction or more in baseline AK count), adverse events and treatment adherence. χ2 test was used to analyse the association between the AK grade and complete clearance rate. p-values < 0.05 were considered statistically significant for this analysis. Local skin reactions, such as erythema, scaling, swelling, crusting, vesiculation and erosions, were classified according to a 4-point scale of severity (none, mild, moderate, severe) 5–7 days after ending the treatment. Adherence was considered correct if 1% tirbanibulin ointment was applied daily for 5 consecutive days. Demographic data, skin phototype, personal history of skin cancer, and previous treatments for AKs were also collected. RESULTS This study reviewed the data on 17 patients with AK, for 22 treatment cycles (14% located on the arms, 41% on the forearms, and the remainder

FAQs

Who was included in the study of 1% tirbanibulin for actinic keratoses on the upper extremities?

Adults aged 18 or above with clinically typical non-hyperkeratotic AK lesions (Olsen grade I–II) on the upper extremities were included. Pregnant patients, those with known sensitivity to tirbanibulin or vehicle components, and those receiving other therapy in the prior 3 months were excluded.

What treatment regimen and how was efficacy measured?

Patients applied 1% tirbanibulin ointment once daily for 5 consecutive days, covering up to a 25 cm2 area. Efficacy was assessed by complete clearance at 60 days (no AKs in the treatment area) and by partial clearance defined as a ≥75% reduction in lesion count.

What were the main safety findings and how severe were local skin reactions?

Local skin reactions were recorded in 8 patients (36%) and were mostly categorized as mild (7 of 8, 88%). Reactions included erythema, scaling, swelling, crusting, vesiculation, and erosions, graded on a 4-point severity scale.

Sep 24, 2026

Uploaded by Elsa