Actinic keratosis
Conditions
Brief summary
The primary efficacy end point is the percentage change in the number of AKs on the side treated with cryotherapy + tirbanibulin at 3 months of follow-up, compared to the side treated with cryotherapy alone.
Detailed description
Percentage of patients with a complete response (100%) in the reduction in the number of lesions and a partial response (greater than or equal to 75%) in the reduction in the number of lesions in V(3) on the side treated with cryotherapy + tirbanibulin, compared to the side only treated with cryotherapy., Differences in the number of new and persistent AKs in V(3) between the area treated with cryotherapy + tirbanibulin and the area treated with cryotherapy alone., Number of local skin reactions and tolerance to treatment on each side., Differences in quality of life scales (comparing each side in V(3) with visit V(0), patient satisfaction and preference between both sides in V(3)., Description of persistent AKs according to Olsen grade (percentage of grade I, grade II and grade III).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy end point is the percentage change in the number of AKs on the side treated with cryotherapy + tirbanibulin at 3 months of follow-up, compared to the side treated with cryotherapy alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with a complete response (100%) in the reduction in the number of lesions and a partial response (greater than or equal to 75%) in the reduction in the number of lesions in V(3) on the side treated with cryotherapy + tirbanibulin, compared to the side only treated with cryotherapy., Differences in the number of new and persistent AKs in V(3) between the area treated with cryotherapy + tirbanibulin and the area treated with cryotherapy alone., Number of local skin reactions and tolerance to treatment on each side., Differences in quality of life scales (comparing each side in V(3) with visit V(0), patient satisfaction and preference between both sides in V(3)., Description of persistent AKs according to Olsen grade (percentage of grade I, grade II and grade III). | — |
Countries
Spain