Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

Summary

To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Timeline

Start

2014-05

Primary completion

2015-03

Completion

2015-03

Outcome

Met primary endpoint

registry Part 2 - Vehicle vs Part 2 - 0.037%; p <0.001; Rate ratio 0.31 (95% CI 0.23 to 0.42); Negative binomial regression NCT02100813 ↗

registry Part 2 - Vehicle vs Part 2 - 0.05%; p <0.001; Rate ratio 0.25 (95% CI 0.18 to 0.33); Negative binomial regression NCT02100813 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ingenol disoxate	Small molecule	—	—

Indications