NCT05387525

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
DRUG	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).
DRUG	Diclofenac Sodium 3% Gel	Participants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days.

Timeline

• Start date: 2022-10-24
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2022-05-24
• Last updated: 2025-02-11

Locations

49 sites across 6 countries: France, Germany, Italy, Poland, Spain, United Kingdom