The aim of the study is to evaluate the efficacy and safety of a combined approach of cryotherapy and tirbanibulin for the treatment of actinic keratosis of the scalp and forehead, repeated every 4 months. A higher rate of complete response is expected with this combination compared to cryotherapy alone, as well as a better response with repeated treatment cycles.
Subject over 18 years old presenting with ≥ 8 typical actinic keratoses (AK), clinically visible or palpable, grade I or II, with at least 4 AK per hemiscalp,
Participants who, in the investigator's judgment, are in good general condition (ECOG ≤ 2),
The AK must be distributed in 2 non-overlapping areas, and of similar grades,
Patient capable of understanding and adhering to the study visit schedule and other protocol requirements,
Clinically atypical and/or rapidly evolving actinic keratoses (AK) in the treatment area, and grade 3 AK according to Olsen classification,
Located somewhere other than the scalp and/or forehead,
Within 5 cm of a wound that is not fully healed or a lesion suspicious for carcinoma,
Prior treatment with tirbanibulin,
Single group
Cryotherapy + Tirbanibulin
DrugTirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months)
Complete clearance of actinic keratosis
Complete clearance rate of actinic keratoses at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.
To determine the 12-month effectiveness of a combined approach using cryotherapy and tirbanibulin.
Complete Clearance of Actinic Keratosis at 12 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.
To evaluate the reduction in the number of actinic keratoses after 2 treatment cycles.
Partial clearance rate (75% reduction in the number of actinic keratoses) at 8 months.
To evaluate the reduction in the number of actinic keratoses after 3 treatment cycles.
Partial clearance rate (75% reduction in the number of actinic keratoses) at 12 months.
To evaluate the reduction in the need for cryotherapy with tirbanibulin.
Number of cryotherapy sessions performed over the entire follow-up period.
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University Hospital, Lille
Lead sponsor
Almirall, SAS
Collaborator
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