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Clinical efficacy and safety of sequential therapy with cryotherapy and topical tirbanibulin 1% in actinic keratoses in transplant recipients: a randomised clinical trial.

Status
Completed
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508091-11-00
Acronym
TIRTRASP
Enrollment
40
Registered
2024-03-27
Start date
2024-05-06
Completion date
2024-12-16
Last updated
2024-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic keratosis

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

Clinica Universidad De Navarra
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026