Safety and Tolerability of Tirbanibulin 1% Treatment of Actinic Keratosis on Face and Scalp in Routine Clinical Practice Across the U.S. (PROAK Study)

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Todd Schlesinger
Mark Lebwohl
James Del Rosso
Vishal A. Patel
Leon Kircik
April Armstrong
Brian Berman
Darrell Rigel
Siva Narayanan
Volker Koscielny
Ismail Kasujee
Neal Bhatia


Tirbanibulin, Actinic Keratosis, Real World Evidence, Safety, Tolerability


Introduction: Actinic Keratosis (AK) has been shown to negatively affect emotional and social functioning and skin-related quality of life of patients [1]. The objective of this analysis was to evaluate safety and tolerability of tirbanibulin in AK treatment, among patients administered tirbanibulin in routine clinical practice across the U.S.

Methods: A single-arm, multicenter, prospective cohort study (PROAK: NCT05260073) was conducted in adult patients with AKs on 25 cm2 on the face or scalp who were newly initiated with once-daily tirbanibulin 1% ointment treatment (5 consecutive days course) as part of usual care. Safety and tolerability endpoints were assessed at Week-8 and Week-24 and included adverse events (AEs), serious AEs (SAE), adverse drug reactions (ADRs), serious ADRs, local skin reactions (LSR), skin scarring and pigmentation (hypo/hyperpigmentation). Number of patients discontinuing treatment because of AEs, ADRs and for any other reasons were also reported. LSR (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) were scored 0-3 (absent-severe) and summed to a composite score (0-18).

Results: A total of 300 patients were included in the safety analysis population (males: 68%; mean age: 67 years; Fitzpatrick skin type II: 89%; AK on the face: 78%). A total of 98% of patients completed the 5-day treatment course. During the study, 5% of patients reported at least one AE, 4% of patients at least 1 SAE, and no patients reported serious ADR. Basal Cell Carcinoma was reported in 1% of patients and Squamous Cell Carcinoma in 2% of patients; all cases were considered not related to treatment.  No patients discontinued the study due to AEs or ADRs. At Week-8, the most reported LSR were erythema (48% mild-moderate, 5% severe) and flaking/scaling (50% mild-moderate, 3% severe). The rest of LSR were reported in 2-8% of patients (8% crusting, 5% swelling, 2% vesiculation/pustulation, and 2% erosion/ulceration) and all were mild-moderate in severity. Mean (min-max) LSR composite score was 0.94 (0-11). At Week-8, scarring or hypo/hyperpigmentation was observed in 1%, 5% and 3% of patients, respectively.  

Conclusions: Once-daily tirbanibulin 1% ointment for 5 consecutive days showed a favorable safety and tolerability profile in the treatment of AK of the face or scalp.

[1] Schlesinger T et al. Skin. 2023;7(3):771-787.


1. Schlesinger T et al. Skin. 2023;7(3):771-787.

2. Blauvelt A et al. N Engl J Med. 2021;384(6):512–20.

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