A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
← catalyst calendarNCT05387525 · readout ≤ 346 d
Sponsored by Almirall, S.A. (industry) · ALM.MC — their whole pipeline →.
Phase
Phase 4
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
447actual
Sites
49
Countries
France, Germany, Italy +3
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 | 2022-10-24 | actual | When the study began enrolling |
| Primary completion | Jul 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-05-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-02-11 | 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 (Klisyri®) 10 mg/g ointment — also filed as Klisyri®
- Drug: Diclofenac Sodium 3% Gel
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF)
measured Up to 3 years
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