A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
Condition(s) studied
Investigational drug(s) / intervention(s)
Tirbanibulin (Klisyri®) 10 mg/g ointment: Participants will apply tirbanibulin 10 mg/g ointment topically for 5 days over 25 cm\^2 of the face or scalp with Actinic Keratosis (AK).
Diclofenac Sodium 3% Gel: Participants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days.
Study summary
The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.
Eligibility
Primary outcome measure(s)
- Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF) — Up to 3 years
Percentage of participants with histologically confirmed invasive SCC in the TF will be reported as assessed by dermoscopy.
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| Almirall Investigation Site 102 | Lille | France | |
| Almirall Investigation Site 103 | Marseille | France | |
| Almirall Investigation Site 104 | Nice | France | |
| Almirall Investigational Site 106 | Paris | France | |
| Almirall Investigational Site 105 | Rouen | France | |
| Almirall Investigational Site 101 | Saint-Priest-en-Jarez | France | |
| Almirall Investigational Site 205 | Augsburg | Germany | |
| Almirall Investigational Site 211 | Bad Bentheim | Germany | |
| Almirall Investigation Site 201 | Bochum | Germany | |
| Almirall Investigational Site 214 | Bochum | Germany | |
| Almirall Investigational Site 212 | Bonn | Germany | |
| Almirall Investigational Site 208 | Detmold | Germany | |
| Almirall Investigational Site 210 | Dresden | Germany | |
| Almirall Investigational Site 204 | Erlangen | Germany | |
| Almirall Investigational Site 206 | Hamburg | Germany | |
| Almirall Investigational Site 213 | Hamburg | Germany | |
| Almirall Investigational Site 207 | Marburg | Germany | |
| Almirall Investigational Site 209 | Merzig | Germany | |
| Almirall Investigation Site 202 | Recklinghausen | Germany | |
| Almirall Investigational Site 309 | Arezzo | Italy | |
| Almirall Investigational Site 302 | Brescia | Italy | |
| Almirall Investigational Site 304 | Genova | Italy | |
| Almirall Investigational Site 308 | Modena | Italy | |
| Almirall Investigational Site 301 | Naples | Italy | |
| Almirall Investigational Site 303 | Reggio Emilia | Italy | |
| Almirall Investigational Site 305 | Roma | Italy | |
| Almirall Investigational Site 306 | Roma | Italy | |
| Almirall Investigational Site 307 | Roma | Italy | |
| Almirall Investigational Site 310 | Rozzano | Italy | |
| Almirall Investigational Site 403 | Lublin | Poland | |
| Almirall Investigational Site 406 | Rzeszów | Poland | |
| Almirall Investigational Site 407 | Warsaw | Poland | |
| Almirall Investigational Site 401 | Wroclaw | Poland | |
| Almirall Investigational Site 402 | Wroclaw | Poland | |
| Almirall Investigational Site 502 | Barcelona | Spain | |
| Almirall Investigational Site 508 | Barcelona | Spain | |
| Almirall Investigational Site 510 | Barcelona | Spain | |
| Almirall Investigational Site 507 | Granada | Spain | |
| Almirall Investigational Site 509 | Granada | Spain | |
| Almirall Investigational Site 503 | Madrid | Spain |
+ 9 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05387525 on ClinicalTrials.gov ↗ ← All trials in Italy