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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
Tirbanibulin 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.
Time frame: 8 months
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months
To evaluate the reduction in the need for cryotherapy with tirbanibulin.
Number of cryotherapy sessions performed over the entire follow-up period.
Time frame: 12 months
To describe the safety and tolerability by treated side at each follow-up visit.
Safety: Local skin reactions assessed throughout the study
Time frame: 12 months
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