Efficacy and safety of sequential treatment with cryotherapy followed by 1% topical tirbanibulin for actinic keratoses in organ transplant recipients: A randomized clinical trial.

Abstract

Actinic keratoses (AKs) are common premalignant lesions, especially in solid organ transplant recipients (SOTRs). Evidence regarding the efficacy and safety of tirbanibulin in this population is scarce. The objective was to evaluate and compare the efficacy and safety of sequential treatment with cryotherapy, followed by 1% topical tirbanibulin, vs cryotherapy monotherapy for AK in SOTRs. A single-center, randomized, intraindividual comparative clinical trial with blinded evaluation was conducted. Each patient had 2 comparable 25 cm² areas: 1 received cryotherapy followed by tirbanibulin after 1 month, and the other received cryotherapy alone. Outcomes included AK count variation, complete and partial response, local skin response, quality of life, satisfaction, and preference. Thirty-seven patients completed the study. At 4 months, AK reduction was significantly higher in the sequential treatment area (-81.6%, SD: 26.9) compared with cryotherapy alone (-53.4%, SD: 32.3; P < .001). Complete and partial responses, lesion persistence, and new AK appearance also favored sequential therapy (P < .05). Adverse effects were mostly mild (mean local skin response: 4.57; range: 1-11). The 4-month follow-up limits long-term assessment. Adherence to home-applied tirbanibulin cannot be fully assured. Sequential cryotherapy and tirbanibulin appear effective and safe for AK in SOTRs, improving lesion clearance and reducing new AK development.