NCT01922050

A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis

Safety and Efficacy of Escalating Doses of Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Chest in Subjects With Actinic Keratosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Part 1: To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	LEO 43204 Formulation 1
DRUG	LEO 43204 Formulation 2
DRUG	LEO 43204 Formulation 1 Dose X
DRUG	LEO 43204 Formulation 1 Dose Y
DRUG	LEO 43204 Formulation 2 Dose XX
DRUG	LEO 43204 Formulation 2 Dose YY
DRUG	Placebo Formulation 1
DRUG	Placebo Formulation 2

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-08-14
• Last updated: 2025-03-06
• Results posted: 2019-02-27

Locations

25 sites across 2 countries: United States, Canada