Journal of the American Academy of Dermatology · 2025
Efficacy and safety of sequential treatment with cryotherapy followed by 1% topical tirbanibulin for actinic keratoses in organ transplant recipients: A randomized clinical trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Morelló-Vicente Ana, Oteiza-Rius Inés, Gómez-González Elisa María, Carrera-Gabilondo Ane, Marcos-Muñagorri Deiane, Antoñanzas-Pérez Javier, Rodríguez-Garijo Nuria, Pilar-Gil María, España Agustín, Nuñez-Córdoba Jorge María, Salido-Vallejo Rafael, Aguado-Gil Leyre
Аннотация
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
LIMITATIONS: The 4-month follow-up limits long-term assessment. Adherence to home-applied tirbanibulin cannot be fully assured.
CONCLUSION: Sequential cryotherapy and tirbanibulin appear effective and safe for AK in SOTRs, improving lesion clearance and reducing new AK development.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
LIMITATIONS: The 4-month follow-up limits long-term assessment. Adherence to home-applied tirbanibulin cannot be fully assured.
CONCLUSION: Sequential cryotherapy and tirbanibulin appear effective and safe for AK in SOTRs, improving lesion clearance and reducing new AK development.