clinical 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
Almirall, S.A.·phase4·active not recruiting·n = 447
Keratosis, ActinicTirbanibulin (Klisyri®) 10 mg/g ointmentDiclofenac Sodium 3% Gel
brief 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.
started
Oct 24, 2022
primary completion
Jul 1, 2027
completion
Jul 1, 2027
last updated
Feb 11, 2025
official title
A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients With Actinic Keratosis on the Face or Scalp
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol