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

NCT01922050 ↗

Phase 1/2 Completed 320 enrolled LEO Pharma

RandomizedSequentialQuadruple-blindTreatment

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

Timeline

Start: 2013-10
Primary completion: 2014-11
Completion: 2014-11

Outcome

Met primary endpoint

paper Reduction in AK count from baseline at Week 8 was significantly higher than with vehicle for all doses of ingenol disoxate gel PMID 28264612 ↗

registry analysis (superiority test); Part 2: LEO 43204 Gel Vehicle vs Part 2: LEO 43204 Gel 0.006; p <0.001; Rate ratio 0.53 (95% CI 0.40 to 0.69) NCT01922050 ↗

Publications

Bourcier M, Stein Gold L, Guenther L, Andreassen CM, Selmer J, Goldenberg G. A dose-finding trial with a novel ingenol derivative (ingenol disoxate: LEO 43204) for field treatment of actinic keratosis on full face or 250 cm2 on the chest. J Dermatolog Treat. 2017 Nov;28(7):652-658. doi: 10.1080/09546634.2017.1303568. Epub 2017 Apr 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ingenol disoxate	Small molecule	0.006 %	Topical
Subject	Ingenol disoxate	Small molecule	0.012 %	Topical
Subject	Ingenol disoxate	Small molecule	0.018 %	Topical