Tirbanibulin 1% Ointment for the Treatment of Hyperkeratotic Actinic Keratosis

Abstract

Actinic keratosis (AK) is a common cutaneous keratinocyte dysplasia resulting from chronic ultraviolet (UV) exposure, typically presenting as erythematous, scaly patches or plaques on sun-damaged skin. AK is recognized as the main precursor of cutaneous squamous cell carcinoma (cSCC). Given the unpredictable potential for progression, current guidelines recommend treating all AKs, irrespective of their clinical grade. However, many approved treatments are not indicated for hyperkeratotic AKs. Among topical therapies, tirbanibulin 1% ointment is a novel synthetic anti-proliferative agent that has shown good results in treating non-hyperkeratotic AKs on the face and scalp, both in clinical trials and real-life experiences. However, its effectiveness in managing hyperkeratotic AKs remains unexplored. A retrospective, single-center study was conducted at the Dermatology Unit of the University of Messina, Italy, between September 2024 and January 2025. The study included 51 hyperkeratotic AK lesions in 32 consecutive patients, treated with tirbanibulin ointment for five consecutive days. At the 2-month follow-up, total clearance (complete lesion resolution) was observed in 54.9% of hyperkeratotic lesions, whereas partial clearance (> 75% lesion reduction) was recorded in 25.5%. The treatment demonstrated a good safety profile, with high patient tolerability. LSRs were observed in 69.8% of patients (n = 22), of which 54.5% (n = 12/22) were classified as moderate, and 45.5% (n = 10/22) as mild. No patient discontinued the treatment due to the onset of adverse events. Our real-world experience suggests the effectiveness and safety of tirbanibulin ointment for the treatment of hyperkeratotic AKs.