Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Summary

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

Timeline

Start

2014-05

Primary completion

2015-05

Completion

2015-05

Outcome

Met primary endpoint

registry analysis (superiority test); Part 2: LEO 43204 Vehicle Gel vs Part 2: LEO 43204 Gel 0.075%; p <0.001; Rate ratio 0.45 (95% CI 0.34 to 0.58); Negative binominal regression NCT02120456 ↗

registry analysis (superiority test); Part 2: LEO 43204 Vehicle Gel vs Part 2: LEO 43204 Gel 0.1%; p <0.001; Rate ratio 0.56 (95% CI 0.44 to 0.73); Negative binominal regression NCT02120456 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ingenol disoxate	Small molecule	0.075 %	Topical
Subject	Ingenol disoxate	Small molecule	0.1 %	Topical

Indications