drugset / Trial / NCT05387525

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

NCT05387525

Phase 4 Active not recruiting 447 enrolled Almirall, S.A.
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-10-24
Primary completion
2027-07
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diclofenac Other / unclassified 3 % Topical
Subject Tirbanibulin Small molecule 10 unknown Topical

Indications