A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis
← catalyst calendarSponsored by Almirall, S.A. (industry) · ALM.MC — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
280actual
Sites
35
Countries
Germany, Italy, Netherlands +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-21 | actual | When the study began enrolling |
| Primary completion | 2025-04-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-25 | actual | The whole study's end, after follow-up |
| First posted | 2023-11-18 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-30 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Keratosis, Actinic
Interventions
- Drug: Tirbanibulin — also filed as Klisyri®
- Other: Vehicle ointment
Primary outcome
what the primary-completion date above is the date OFPercent Change From Baseline in Lesion Count at Day 57
measured Baseline, Day 57
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-01-31 · 12.9 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-07-25 · 3.5 MB · SAP_001.pdf
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